山西省化妆品注册人、备案人、受托生产企业：为规范化妆品生产质量管理，推动化妆品企业落实质量安全主体责任，促进产业健康发展，根据《化妆品监督管理条例》《化妆品生产经营监督管理办法》《化妆品生产质量管理规范》《化妆品生产质量管理规范检查要点》等法规规章要求，山西省药品监督管理局组织开展2025年度化妆品注册人、备案人、受托生产企业执行《化妆品生产质量管理规范》情况自查工作，现就有关事项通知如下：一、自查主体山西省取得化妆品生产许可的生产企业、国家药监局“普通化妆品（牙膏）备案管理系统”中注册的山西省内化妆品注册人、备案人。二、自查内容（一）生产经营概况：包括企业从业人员、设施设备投入和生产质量管理体系建设情况，产品注册（备案）、生产经营总体情况，企业组织机构、关键岗位人员、生产条件及其他重大事项变化情况；（二）质量管理情况：对照《化妆品生产质量管理规范检查要点》规定，企业主体责任落实情况，发现的问题及相应的整改等情况；（三）产品质量安全评价情况：企业及其销售产品接受各级监管部门监督检查、产品抽检、行政处罚情况；企业质量安全事故、媒体曝光、群众投诉、不良反应、不合格产品召回及处置等情况；（四）委托（受托）生产情况：委托其他企业生产或接受其他企业委托生产情况；（五）停产、复产情况。三、其他事项（一）化妆品注册人、备案人、受托生产企业年度例行自查报告的数据截止时间为每年12月31日，报送时间为次年3月31日前。（二）各单位按照通知要求组织自查，2025年3月31日前通过进入“山西政务服务网站-药品智慧监管专区-企业信息”报送自查情况。（三）各单位未按规定向药品监督管理部门提交质量管理规范自查情况的，将按照《化妆品监督管理条例》第六十二条的规定依法处置。附件：《化妆品生产质量管理规范》自查工作填报指南山西省药品监督管理局2026年3月10日（主动公开）附件：

为加强医疗器械质量监督管理，保障公众使用医疗器械产品安全、有效，省药品监督管理局组织对一次性使用无菌注射器等942批次医疗器械产品开展了监督抽检。现将抽检检出的结果公告如下：一、被抽检项目全部符合标准规定的医疗器械产品有938批次产品（详见附件1）。二、被抽检项目不符合标准规定的医疗器械产品有4批次产品（详见附件2）。三、对上述抽检中发现的不符合标准规定的医疗器械产品，湖北省药品监督管理局已要求被抽检单位所在地药品监督管理部门按照《医疗器械监督管理条例》等法规规章要求，对相关单位进行调查处理，督促企业查明原因、制定整改措施并限期整改。对已上市的不合格产品必须采取相应的召回纠正措施，确保产品的质量安全有效。涉及外省企业的，已通报当地药品监管部门。附件：1.2025年湖北省医疗器械抽验符合标准规定产品名单      2.2025年湖北省医疗器械抽验不符合标准规定产品名单湖北省药品监督管理局  2026年3月10日     

按照《互联网药品信息服务管理办法》的有关规定，根据企业申请，现注销山西医路通盛健康管理有限公司等3家企业《互联网药品信息服务资格证书》。特此通告。   附件：山西省药品监督管理局注销《互联网药品信息服务资格证书》企业名单山西省药品监督管理局2026年3月10日（主动公开）附件：山西省药品监督管理局注销《互联网药品信息服务资格证书》企业名单序号企业名称网站名称证书编号服务性质网站域名及IP地址地址1山西医路通盛健康管理有限公司山西医路通盛健康管理有限公司(晋)-非经营性-2023-0002非经营性/sxylts.cn/139.129.151.41/ 山西省太原市迎泽区文庙街道迎泽大街27号万邦国际9层928、929、930、931室2长子县勇芳大药房连锁有限公司长子县勇芳大药房连锁有限公司(晋)-非经营性-2021-0025非经营性/www.yongfangliansuo.com/39.107.225.135/ 长子县丹朱镇泊里村3运城市盐湖区德一堂大药房运城市盐湖区德一堂大药房(晋)-非经营性-2024-0205非经营性/deyitangdayaofang.com/101.36.223.143/ 山西省运城市盐湖区涑水街紫云轩小区东门南11号商铺

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据河南医圣堂药业有限公司南阳分公司申请，现注销河南医圣堂药业有限公司南阳分公司的《药品经营许可证》（证书编号：豫AA377000732）。　　特此公告。　　附件：河南医圣堂药业有限公司南阳分公司《药品经营许可证》有关信息表　　2026年3月11日附 件河南医圣堂药业有限公司南阳分公司《药品经营许可证》（批发）有关信息表企业名称企业法人（负责人）主要负责人质量负责人经营方式经营范围经营地址仓库地址证书编号河南医圣堂药业有限公司南阳分公司张新杨杰姚学文批发中药饮片***河南省南阳市卧龙区卧龙岗街道车站南路3366号院内医圣堂健康产品研发基地办公楼4楼河南省南阳市卧龙区车站南路3366号8#厂房《药品经营许可证》（证号：豫AA377000732）

根据《药品管理法》、《药品生产监督管理办法》有关规定，经现场检查并综合评定，现将福建海峡金芝堂药业有限公司《药品生产质量管理规范》符合性检查结果公告。企业名称检查地址检查范围检查时间类型检查结果福建海峡金芝堂药业有限公司福建省平潭县金井镇顺意路16号平潭海峡医药健康产业园2#厂房一至三层中药饮片（净制、切制、炒制、酒炙、醋炙、蜜炙、煅炙、蒸炙、煮炙、盐炙）2026年1月7～9日依申请符合福建省药品监督管理局2026年3月10日

各第二类、第三类医疗器械经营企业：　　依据《医疗器械监督管理条例》和《医疗器械经营质量管理规范》（2024年7月实施）相关要求，现组织我市医疗器械经营企业2025年度自查报告填写工作：　　一、填报主体　　依据《医疗器械经营质量管理规范》（2024年7月实施）第十二条，从事第二类、第三类医疗器械经营的企业应当提交上一年度的自查报告。自查报告内容应当真实、准确、完整和可追溯。　　二、填报时间　　2026年3月11日14：00-2026年4月30日23：59　　三、填报地址　　https://zwfw.yjj.beijing.gov.cn　　四、填报要求　　依据《医疗器械经营质量管理规范》（2024年7月实施）第十二条，年报报告内容应当真实、准确、完整和可追溯。　　五、填报操作指南　　图文版用户手册见附件。　　六、其他要求　　二三类医疗器械经营企业年报系统近期用户访问量较大，如遇到登陆或操作问题，您可以：　　1.发送电子邮件至jszc2025@163.com。详细描述“办理何类事项时遇到什么问题”，注明联系方式并上传问题截图，工作人员将在1个工作日内给予答复（建议优先发送邮件，技术热线繁忙）。　　2.拨打技术支持热线：400 900 1866。服务时间：9:00-18:00（工作日）　　有关填报内容的疑问可咨询各区监管部门：附件：二三类医疗器械经营企业企业年度自查报告_用户手册　　北京市药品监督管理局　　2026年3月10日

　　按照《医疗器械监督管理条例》有关规定，根据企业申请，国家药品监督管理局注销以下4家企业共9个产品的医疗器械注册证：　　一、蒲兰纳医疗器械有限公司Planer Limited的1个产品：胚胎培养箱Incubators，注册证编号：国械注进20222180361。　　二、创生医疗器械（中国）有限公司的4个产品：脊柱通用后路内固定器，注册证编号：国械注准20173134720；脊柱通用前路内固定器，国械注准20183131572；脊柱通用后路内固定器，注册证编号：国械注准20153130118；椎间融合器，注册证编号：国械注准20173131463。　　三、江苏双羊医疗器械有限公司的3个产品：钛质接骨板（加压和保护性接骨板），注册证编号：国械注准20163130368；钛质接骨板（解剖型接骨板），注册证编号：国械注准20163130451；钛质接骨板（DHS、DCS），注册证编号：国械注准20163130369。　　四、广东宝莱特医用科技股份有限公司的1个产品：血液透析器，注册证编号：国械注准20223100152。　　特此公告。　　　　　　国家药监局2026年3月9日

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Aurelio SahagunPresident and Chief Executive OfficerExactech, Inc. dba Advita Ortho2320 Nw 66th CtGainesville,FL32653-1630United Statesaurelio.sahagun@advita.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 720250December 19, 2025Dear Mr. Sahagun:During an inspection of your firm located in Sarasota, Florida from July 15, 2025, through July 25, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Equinoxe Reverse Shoulder Compression Screw along with other accessories of the Equinoxe Reverse Shoulder System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.We received a response from Mathew Collins, Vice President of Quality dated August 15, 2025, along with response updates concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1) Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications when deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a). For example, your firm failed to adequately establish production and process control procedures to ensure that devices conform to specifications.A. Your firm failed to define(b)(4)specifications and testing for polymer powder fabricated into UHMWPE molded products to ensure device components meet specified requirements. The document titled, “Ultra-High Molecular Weight Polyethylene (UHMWPE) ETS-0121 Rev. J”, released 02/23/2022 and “Compression Molded UHMW Polyethylene ETS-0122 Rev. L”, released 06/27/2022 call out(b)(4)and(b)(4)(Implants for surgery –(b)(4)–(b)(4)respectively. Your firm has no records of(b)(4)testing for lots of(b)(4)products to verify compliance with required(b)(4)specifications of(b)(4). The Certificate of Conformance values for lots are based on(b)(4)qualification testing of polymer powder fabricated into(b)(4)products rather than actual manufactured products.1. Investigators noted that(b)(4)measurement value of(b)(4), documented on the Certificate of Conformance for part number(b)(4), is not based on testing conducted on molded/fabricated parts. Rather the nominal values documented on this Certificate of Conformance, are based on(b)(4)testing performed on the(b)(4)shipment of(b)(4)raw powder, identified with lot number(b)(4), initially received on or around December 2021. Your firm declares compliance to(b)(4)Implants for surgery –(b)(4)–(b)(4)which notes the physical property requirements of(b)(4)molded products and states in part, “(b)(4).” The qualification testing is documented on Technical Memo TM-2021-1578, with approval dates 01/18-19/2022, and the(b)(4)test result were documented as(b)(4).B. Production and process procedures do not clearly define process controls necessary to ensure conformance to specifications. Your firm failed to adequately document instructions, standard operating procedures, and methods that define and control the manner of production.1. The work instructions do not define and control the manner of production, including in-process inspection of a critical specification and use of the(b)(4)tool. The Equinoxe Reverse Shoulder Torque Screw devices critical specification for break-point dimension inspection ((b)(4)) relies on(b)(4)inspection with significant operator variability. However, Work Instruction titled, Complete and Document Inspection of Machined Product at Sarasota- Machining 701-105-945 Rev. D, also does not clearly or explicitly outline the production and processing controls or provide step-by-step directions for the required, in-process inspections of the Equinoxe Torque Screw device, including specific instructions, equipment needed, process or product parameters or specifications, or inspection requirements.i. FDA investigators noted that an operator was performing this inspection step that required(b)(4)to undergo and pass this in-process inspection step out of a sample size of(b)(4). At the time the investigators observed this in-process inspection being performed, two of the required(b)(4)had undergone and passed this inspection step. The investigators noted that a sample unit, identified the torque screw as passing and meeting the required specification of(b)(4), from point A to B. However, investigators reviewed the measurements and noted that the unit did not pass this(b)(4)inspection test as the unit did not appear to fall completely within the specified(b)(4)lines of the(b)(4)tool image that reflect tolerance limits. Three nonconforming devices were later scrapped as noted on the scrap log and Production Events log.2. Manufacturing procedures do not adequately define process controls, in-process inspections, or equipment specifications. Work Instruction titled, Machine Equinoxe Reverse Shoulder Liner at Sarasota-Machining 701-105-896 Rev. C, released 04/15/2024, does not clearly or explicitly outline the production or processing controls or provide step-by-step directions for the manufacture of the Equinoxe Shoulder Liner device including specific instructions, equipment needed, process or product parameters or specifications, or inspection requirements. Additionally, your firm’s Work Instruction titled, Complete and Document Inspection of Machined Product at Sarasota- Machining 701-105-945 Rev. D, also does not clearly or explicitly outline the production and processing controls or provide step-by-step directions for the required, in-process inspections of the Equinoxe Shoulder Liner device, including specific instructions, equipment needed, process or product parameters or specifications, or inspection requirements. Neither of these Work Instructions document specific instruction on how to perform this inspection test, such as use of the(b)(4)tool, and operator(b)(4)is not addressed. Furthermore, no Operational Qualification was documented for(b)(4)machining processes, of the Equinoxe Polyethylene Shoulder Liner device and devices do not undergo(b)(4)in-process or final testing.Your firm’s responses are not adequate. The responses note that the root causes and contributing factors of the process control deficiencies include inconsistent enforcement of validation requirements, gaps in operator training on comparator-based inspections, and absence of formal inspection method qualification. In addition, the responses note that these deficiencies have systemic implications across your firm’s manufacturing operations and as well design transfer activities. Your firm’s responses describe corrections that include a manufacturing and process hold,(b)(4)inspection of existing inventory during process hold and a Field Action for(b)(4)Humeral Shoulder Liners. Your responses also describe corrective and preventative actions under CAPA 2025-30 that include: validation remediation for relevant manufacturing processes across Sarasota and Gainesville; SOP and work instruction redesign and training; inspection method qualification and retention of coordinate measuring machine reports; develop layered process audit work instructions and integration into QMS trending; SOP update for initial out of specification handing; and design transfer and process validation readiness. Your firm’s responses do not describe, and list remediation activities or products associated to legacy design transfer issues across manufacturing operations at your Sarasota and Gainesville facilities. The activities under CAPA 2025-30 along with the verification of effectiveness criteria, are in progress and extend through March 2026.2) Failure to adequately establish and maintain procedures for corrective and preventative action, as required by 21 CFR 820.100(a). For example:A. The procedure for Corrective and Preventive Actions Procedure, 701-103-137, Rev. AB, dated 6/11/2025 does not identify production events as nonconformities or quality data. A Production Event (PE) is defined as an event generated in(b)(4)utilized for processing electronic device history records, due to a deviation from pre-established product or process specifications. Production Events ((b)(4)documented events) are not analyzed as quality data sources or escalated to CAPAs where appropriate. Investigators noted that from 07/01/2023 to 7/25/2025 there was incomplete documentation maintained or available to demonstrate which Production Event entries were documented and managed as nonconformances. Additionally, no documentation was maintained or available to demonstrate that any Production Events were further assessed or analyzed as quality data sources.B. CAPAs 2023-005 and 2025-005 addressing environmental control specifications for(b)(4)storage were verified as effective and closed, yet environmental monitoring data from March 2024 to current showed your firm continued to exceed allowable temperature and humidity limits. Temperature specifications were changed from(b)(4)to(b)(4)in June 2025 after historical data showed consistent excursions. The pFMEA for the(b)(4)Molding Process, FMEA-000445, Rev A, dated 8/1/2024, discusses product and process impact with high temperatures and humidity, and the potential failures related to air conditioning (HVAC). Specifically, the effect of high moisture in(b)(4)may impact the material strength.Your firm’s responses are not adequate. Your firm’s responses note corrective actions under CAPA 2025-31 that include: CAPA procedural updates for verification of effectiveness; updates to Quality System’s governance and Management Review process adding additional sources of quality data (Production Events, Work in Process Scrap , environmental monitoring data, etc.); updates to software validation to include evaluation for the identification of critical to quality attributes for continuous monitoring; updates to Document Control related to the QMS process change and the determination of quality data outputs for continuous monitoring; and CAPA remediation efforts for verification of effectiveness. Your responses do not describe any retrospective review necessary to assess whether quality data such as Production Events, Work in Process Scrap, etc. or other critical to quality data attributes represent nonconformances or other quality issues that may require the initiation of a CAPA. The activities under CAPA 2025-31 along with the verification of effectiveness criteria, are in progress and extend through March 2026.3) Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm failed to identify, document, evaluate nonconforming product including the need for investigation and notification of the persons or organizations responsible.A. There was no written procedure for handling “Production Events (PE)” identified during manufacturing. The Nonconforming Product Handling Procedure, 701-103-013 Rev. AK, dated 9/13/2024, does not include a process to elevate Production Events to a nonconformance, despite the potential for rework may occur. Production Event entries included those for multiple inspection failures found at various stages in the manufacturing process (in-process inspection and QC inspection). For example:1. Failure of product’s dimensional specifications ((b)(4)failure,(b)(4)failure,(b)(4)failure,(b)(4)radius) that may correlate with high scrap rates for dimensional defects.2. Surface quality defects that include those for molding contamination: inclusions on articulating surface and mold marks.3. Machining process issues from setup and tooling that may create recurring dimensional problems (undersize stems on “(b)(4)”, undersized pin head, undersize due to a fixture issue, damaged threads, smooth and inconsistent threads, burrs in threads).4. Packaging issues that include wrinkles on seal, crease in seal, cuts in bag, score mark, seal integrity, loss in vacuum, nonuniform seal, loose fibers and black particles, hair, black particles embedded in bag.B. The WIP Scrap Events Collection procedure does not define threshold levels for when internal WIP scrap should be documented as nonconformances. While supplier receiving inspection has defined thresholds ((b)(4)defect rate), no similar thresholds exist for internal operations. Scrap log includes entries for nonconforming product associated with manufacturing process control deficiencies which include:1. Machining setup issues where numerous entries are labeled as set up, "setup part," "dial in" and tooling/fixture issues labeled as "tool broke," “bad mold tool”, "worn tool," "loose tool” and “wrong offset” resulting in scrap from dimensional and product quality problems (button height, overall thickness, overall length, thread noting dings and dents).2. Molding process issues resulting in scrap from:i. Equipment power issues labeled as “power outage”, “power failure”, “press failure”, “power turned off”;ii. Hydraulic issues (hydraulic Hit/loss, pressure drop);iii. Heating and cooling failure (pumps not turned on);iv. Manufacturing process control issues (“wrong recipes”, “tool not set up”, “missfil”, “not properly blowing out”) resulting in scrap from “flash leakage”, “inclusions on surface” and “under/over” weight product3. Product finishing issues from “over polishing”, “over blasting” and “thread chip wrap” resulting in nonconforming product dispositioned as scrap.4. Operator training issues as “operator error” entries for the machining, molding and finishing manufacturing processes resulting in dimensional and cosmetic nonconforming product dispositioned as scrap.Your firm’s responses are not adequate. Your firm’s responses note that corrective actions under CAPA 2025-31 that included: the coordination of the nonconformance program with the Production Events (PE) and work in process (WIP), and training development. Your firm’s retrospective review of WIP and PE does not include the rationale for timeframes selected. For example, you identified July 2024 through August 2025 for retrospective review; however, FDA investigators reviewed WIP and PE data from 7/01/2023 through 7/25/2025. In addition, we disagree with your investigation that raw data and pivot tables for Production Events and WIP Scrap entries revealed that the vast majority ((b)(4)) of Production Events were benign in nature, and resolved via appropriate mechanisms (e.g.(b)(4),(b)(4)fix, and approved reworks). Additionally, it is not clear from production event logs collected during the inspection how the in process and quality control inspection failures were handled.Your firm notes that although there were gaps in the inconsistent classification and escalation of quality events, that the nonconformances do not indicate a risk to product. FDA disagrees with this assessment in that this does represent a potential risk to distributed product since the FDA inspection and your firm’s investigation identified gaps with QC work instructions and training. Specifically,(b)(4)in-process inspection using manual(b)(4)and(b)(4)lacked formal work instruction to define the method, criteria, or documentation required. This created variability in execution and no documented evidence of consistency or repeatability. Your firm’s CAPA Review Board (CRB) identified this as a systemic breach of regulatory and QMS requirements; however, the assessment noted that it did not require a reportable field action. FDA remains concerned with the potential distribution of nonconforming product.The activities under CAPA 2025-31 along with the verification of effectiveness criteria, are in progress and extend through March 2026.4) Failure to adequately establish and maintain procedures to ensure that environmental conditions do not adversely affect product quality, as required by 21 CFR 820.70(c). For example, your firm failed to adequately establish procedures to ensure your environmental controls are being maintained as specified and that your environmental control systems are adequate and functional.A.(b)(4)Raw Material Storage, QWI-000185, Rev A, dated 4/30/2024 and the current procedure, Rev B, dated 6/10/2025 were not followed for backup environmental monitoring when the(b)(4)system fails in the Sarasota Molding Facility.(b)(4)system graphs from March 2024 to July 2025 of both temperatures and relative humidity levels were commonly and routinely recorded to be outside of the specified, nominal limit levels.B. A Deviation/Change Request, dated 05/27/2025, was “Due to a faulty environmental monitoring sensor ((b)(4)) located in the controlled environment fill room, the sensor will be unplugged, and environmental monitoring will occur using a calibrated data logger for both temperature and humidity”. Only one of(b)(4)poly fill rooms is monitored by the(b)(4)system, with assumption that(b)(4)rooms maintain same conditions despite physical wall separation.The adequacy of your firm’s responses cannot be determined at this time. Your responses note that corrective and preventative actions under CAPA 2025-033 included the environmental monitoring system enhancements; procedural revision to environmental monitoring excursion; training; updates to risk documents; new procedure to be used to document the facility modification; and defining environmental conditions of(b)(4)resin and molded components. The activities under along CAPA 2025-033 with the verification of effectiveness criteria, are in progress and extend through March 20265) Failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product, and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm failed to follow the procedures for Supplier Quality Management, 701-103-077, Rev AH, dated 10/31/2023. The FDA investigators noted that(b)(4)., the sole supplier of critical(b)(4)powder, has not received a required on-site audit per Supplier Quality Management Procedure Section 5, Step F, Item 2.C. The last supplier evaluation was conducted in September 2020, with no reevaluation when current procedures were implemented in October 2023. Additionally, there is no signed quality agreement as required per the procedure Section V, Step C, item 4.Your firm’s pFMEAs for the(b)(4)molded products document considers the raw(b)(4)powder, a critical component of the processing and quality of the finished devices. In the Process FMEA Process Failure Mode and Effects Analysis(b)(4)Compression Molding Process, FMEA-000445 Rev. A, DCRTC-00194, dated 8/1/2024 notes that if the(b)(4)is not properly received from the supplier and in conformance with the specifications, this could potentially lead to product impact with quality failures, incorrect traceability, higher product scrap or degraded mechanical characteristics.The FDA inspection noted that there were no records to demonstrate that your(b)(4)powder supplier, has or is maintaining environmental controls and storage conditions of the supplied(b)(4)powder component. The current lot of(b)(4)powder in use by your firm, lot number(b)(4), was first qualified in 2021, and all(b)(4)powder received since then, have been identified with the same lot identification. Documentation demonstrates the initial qualification of lot(b)(4)in 2021; however, your firm has received approximately(b)(4)shipments of the same lot of(b)(4)powder from(b)(4), since 2021 to 7/25/2025.The adequacy of your responses cannot be determined at this time. Your responses note the following activities being handled under CAPA2025-034: Supplier Quality Management SOP revision; the reevaluation of approved suppliers; the integration of supplier checks into design transfer activities; revise On-Site Audits and initiate Quality Agreements and On-Site Audits; and initiate Quality Agreements of(b)(4)powder. Many of the activities under CAPA2025-034 along with the verification of effectiveness criteria, are in progress and extend through June 2026. Therefore, we cannot determine the adequacy at this time.6) Failure to adequately establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm failed to capture the training of employees as described in the Competency and Training Procedure, 701-103-087, Rev. AB, dated 7/9/2024. FDA inspection noted that:A.(b)(4)employees working in manufacturing did not have required QC inspection tools documented in their training records, not meeting the requirement that employees perform all necessary training prior to task execution without oversight.B. The procedure states that all retraining shall be documented and recorded as part of the employee’s training record. In the review of 11 nonconformance reports, 7 nonconformance reports identified operator error as the root cause. Retraining was not identified as an action item in 6 of 7 of the reports reviewed.Your firm’s responses are not adequate. Your responses note the following activities being handled under CAPA 2025-035 include implementation of Task-Level Training Controls; development of work instructions and inspection tools; documented on the job training; the revision of Nonconforming Product Handling Procedure to enforce training; and revision of competency and training procedure. Your firm’s response does not describe any necessary training as part of the design transfer activities associated to a new manufacturing or inspection process. The activities under CAPA 2025-035 along with the verification of effectiveness criteria, are in progress and extend through April 2026.7) Failure to adequately establish procedures for acceptance activities, as required by 21 CFR 820.80(a). For example:A. Your firm failed to identify the correct work instructions that applies to manufacturing personnel when using(b)(4)to produce products for the Truliant Knee 02-029-190-4300 Short Headed Pin For Syringe Pin Puller, Alteon Hip 180-165-20 Alteon 6.5MM Screw, 20MM, and the Equinoxe Shoulder Torque Defining Screws. The work instructions listed did not call out for manufacturing personnel to use the Manufacturing of Product in(b)(4)Work Instruction, 701-105-1121, Rev D, effective date 2/28/2024. The work instructions are:1. Machining of Holding Pins at Sarasota- Machining Work Instruction 701-105-929, Rev. H, effective date 7/15/20252. Machining of 6.5mm Alteon Cancellous Bone Screw at Sarasota-Machining and Finishing Work Instruction, 701-105-964, Rev. C, effective date 6/22/20213. Manufacturing of Torque Defining Screws at Sarasota-Machining and Finishing Work Instruction, 701-105-1071, Rev B, effective date 11/05/2021B. Your firm failed to establish procedures or work instructions for two critical QC inspection tools used for the(b)(4)inspection process for the Equinoxe torque defining screw devices and for the(b)(4)inspection process for the Equinoxe shoulder liner device.The adequacy of your responses cannot be determined at this time. Your responses note that the following activities are being handled under CAPA 2025-036: updates on work instructions that support(b)(4)-controlled tasks and inspection operations; develop inspection tools and work instruction in conjunction with CAPA 2025-35; and work instruction impact review across similar product. The activities under CAPA 2025-036 along with the verification of effectiveness criteria, are in progress and extend through March 2026.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Melissa Michurski, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 720250” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla at Rafael.padilla@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC: Christine Thomas, Chief Quality, Clinical and Regulatory Officer, christine.thomas@advita.com

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-47Product:DrugsRecipient:Mr. M. Jayapal ReddyChief Executive OfficerTentamus India Private Limited3-31/33, Part Sy. No. 123, 124, 125 & 142, KompallyQuthbullapurHyderabad500014TelanganaIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-47March 3, 2026Dear Mr. Reddy:The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Tentamus India Private Limited, FEI 3010960741, at 3-31/33, Part Sy. No. 123, 124,125 & 142, Kompally, Quthbullapur, Hyderabad, Telangana State, from August 14 to 22, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, the drug products you tested are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).Furthermore, during the inspection you delayed or limited access to records requested. Due to your delay and limiting access to records during the inspection, the drug products you tested are also deemed adulterated within the meaning of section 501(j) of the FD&C Act, 21 U.S.C. 351(j).We reviewed your September 15, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) failed to ensure that all CGMP records were retained and available for review. Our investigator discovered two garbage bags containing torn analytical records, including chromatographic results, unidentified number lists, and impurity method validation spreadsheets with handwritten notes. For the method validation study, official records contained only handwritten values, while the original data was discarded in the garbage bags. This practice violated your lab documentation standard operating procedure (SOP) which prohibits destroying records or instrument printouts due to errors and requires filing such documents with original data for traceability with proper justification.Additionally, laboratory staff used unofficial personal diaries to record procedures, analytical observations, results, method modifications, and deviation descriptions. Your firm lacked procedures to control the use of these personal diaries and to ensure proper retention of all CGMP data.In your response, you state you opened an investigation and that the validation documents in the garbage bags were not related to drug products destined for the United States. Your response is inadequate. Irrespective of the ultimate use or intended purpose of the validation documents, because your firm operates with a single set of procedures, equipment, and practices for all products tested at your facility, including those destined for the United States, all testing and data must be handled appropriately and in accordance with established procedures. Furthermore, your response fails to describe immediate corrective actions to prevent the destruction of CGMP data or to prevent the use of unofficial diaries to record CGMP data.Reliability of data is compromised when there is a failure to maintain complete records of the conditions and data associated with all tests. Furthermore, the lack of complete data compromises the QU’s ability to exercise its function of ensuring compliance to applicable standards.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you test. See FDA’s guidance documentData Integrity and Compliance With Drug CGMP: Questions and Answersfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We acknowledge that you are using multiple independent third-party consultants to audit your operations and assist in meeting FDA requirements.In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies and omissions in data records and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third-party.o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.o A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third-party with specific expertise in the area(s) where potential breaches were identified should evaluate all data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of the drugs you test. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drug testing results, such as notifying your customers, conducting additional testing, recommending additional studies to assure stability, drug application actions, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.o A commitment to have a qualified consultant conduct comprehensive annual audits, for at least two years, to assist in evaluating corrective action and preventive action (CAPA) effectiveness after you have executed your data integrity remediation protocol.o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by an independent quality assurance function, along with expertise from outside entities whenever needed).o A status report for any of the above activities already underway or completed.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. Also describe how top management supports quality assurance and reliable operations including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.A list of all method validations performed by your firm since 2022. Provide a third-party assessment of these method validations to determine whether additional development or validation studies are needed. For any method validations requiring revision, provide all correspondence sent to your clients informing them of the need for revisions.2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Laboratory DeviationsYou failed to adequately investigate laboratory deviations. An unofficial audit form was used to document laboratory deficiencies found on July 7, 2025, including a discrepancy in which microbiological sample plates could not be located in an incubator despite a logbook entry indicating the plates had been placed there(b)(4)earlier. The audit observations were made approximately six weeks before the inspection, but no CAPAs were listed on the form, and the findings were not included in the QU’s deviation and CAPA tracking program.In your September 15, 2025 response, you stated that the audits were conducted as(b)(4)operational checks to strengthen quality oversight, and you acknowledge the absence of a formal standard operating procedure (SOP) for such practices. You provided an updated SOP that proceduralizes routine process audits and committed to completing CAPAs for the observed items.Your response is inadequate. The updated SOP allows for routine identification and correction of deficiencies outside of the Quality Management System (QMS) without providing guidelines on when personnel must use the QMS framework for identifying and correcting deficiencies. Without QMS tracking and trending of deficiencies and corrections, the QU cannot ensure adequate CAPAs are implemented, potentially allowing operational deficiencies to persist and compromising testing control.Unexplained Out of Specification (OOS) ResultsYou failed to adequately investigate OOS results. On August 31, 2023, you tested(b)(4)for Total Aerobic Microbial Count (TAMC), and on September 11, 2023, reported the results as “Too Numerous to Count (TNTC).” On September 30, 2023 and November 3, 2023, you issued revised test reports for the same sample and test date, listing the TAMC result as passing, with a result of

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-48Product:Drugs,Over-the-Counter DrugsRecipient:Mr. Bernard FraisseFounder and CEOFareva Morton Grove1 Avenue President Wilson75016ParisFranceIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-48March 3, 2026Dear Mr. Fraisse:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fareva Morton Grove, FEI 1410794, at 6901 Golf Road, Morton Grove, Illinois, from August 4 to 12, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your September 3, 2025, response to our Form FDA 483 in detail, and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).Your firm utilizes(b)(4)as a component to manufacture your over-the-counter (OTC) drug products. However, you failed to design and control your(b)(4)to ensure reliable production of(b)(4). The system was unsuitable to ensure both chemical and microbiological quality attributes.For example, your(b)(4)design did not ensure(b)(4). Notably, the system consistently failed to meet the(b)(4)specification. The performance qualification report for your(b)(4)included over(b)(4)of(b)(4)-sampling data, showing that most samples failed USP(b)(4)standards. Despite obtaining failing data, you approved the qualification study in(b)(4). Subsequent(b)(4)data obtained from August 2023 through August 2025 showed that nearly all your(b)(4)samples continued to fail the(b)(4)specification for(b)(4). You used(b)(4)from this(b)(4)in the manufacture of finished drug products.Your(b)(4)also had numerous points within the system that can harbor(b)(4), dead-legs), including some points-of-use located in the drug production area. Your firm was aware of the presence of dead-legs in the system.Deficient(b)(4)design can foster the development of biofilms, resulting in significant sporadic spikes in microbial levels of(b)(4)used for formulation and cleaning. Examples of gram-negative bacteria found in your(b)(4)include Pseudomonas aeruginosa and Serratia marcescens (a familyYersiniaceaemicrobe).In your response, you state that you plan to redesign your(b)(4)to eliminate dead-legs, add(b)(4)equipment, and qualify the system for the production of(b)(4). Your response is inadequate. You do not address your quality unit’s protracted insufficient action to address a long-standing pattern of failing test results of the(b)(4)utilized to make drug products.We acknowledge your commitment to stop using(b)(4)from your(b)(4)to manufacture drug products until the system can be remediated. We also acknowledge your commitment to use purchased(b)(4), in the interim.(b)(4)must be suitable for its intended use. Systems used to produce(b)(4)must be adequately designed, controlled, maintained, and monitored. The monitoring program should include routine testing to ensure that appropriate chemical and microbiological limits are consistently met.In response to this letter, provide:A comprehensive remediation plan for the design, control, and maintenance of the(b)(4), including:o a comprehensive evaluation of vulnerabilities of(b)(4)design and control, and summarize all deficiencies found in the system. The summary should, at a minimum, describe various system characteristics that were assessed for adequacy (for example, system temperature, materials of construction, slope, identified dead-legs, stagnant locations, unsanitary fittings, flow velocity, maintenance requirements).o revised procedures governing your program for ongoing control, maintenance, and monitoring to ensure the remediated system consistently produces(b)(4)that meets(b)(4)monograph specifications and appropriate microbial limits.o a corrective action and preventive action (CAPA) plan that corrects all(b)(4)design and control deficiencies. Include your plans for new system installation, or extensive design remediation (for example, removal of all dead-legs); preparation of a system-validation protocol; and the planned timeline for completion of thorough(b)(4)validation studies.Your plans for improved(b)(4)monitoring, including but not limited to the routine microbial testing of(b)(4)and appropriate limits (objectionable microbes, total count alert/action limits) to ensure the(b)(4)acceptability for use in each batch of drug product produced by your firm. Ensure that your(b)(4)total-count limits are appropriately stringent, in view of the intended use of each of the products produced by your firm.A detailed risk assessment addressing the potential effects of the observed(b)(4)failures on the quality of all drug product batches currently in U.S. distribution. Specify the actions you will take in response to the risk assessment, such as customer notifications and product recalls.2. Your firm failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(b)).You failed to ensure adequate microbiological testing for each batch of your drug products before release. For example, you failed to follow your procedure SOP L6082, “Identification of Gram-Negative Rod Bacteria and Yeast,” which requires the identification of all gram-negative rods found in your samples. You had not performed the required identification of gram-negative rods recovered from your drug products since January 2025, despite seeing an increase in colony forming units (CFUs) from September 2024 through January 2025.Testing is essential to ensure that the drug products you manufacture conform to all predetermined quality attributes appropriate for their intended use. Because you lacked adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished-product specifications and are suitable for release to consumers.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard-quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).You failed to accurately document drug product microbiology testing results. Specifically, you did not contemporaneously record negative results for sample plates on which no microbiological growth was observed. Your procedure required positive plates to be entered contemporaneously, while blank entries were later automatically documented as zero values. Our inspection of the laboratory revealed a plate that had been counted and found to contain 20 CFUs. However, your firm had discarded the plate without recording the microbial levels.You were also unable to provide complete(b)(4)microbial sampling results from the(b)(4). Results existed in mixed formats (for example, paper-based and electronic entries), with some data missing.Collectively, these deficiencies indicate a significant risk of systematic underreporting of microbial findings.Reliability of data is fundamentally compromised when there is a failure to record data or to maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the ability of your quality unit (QU) to exercise its function of ensuring compliance to applicable standards.In your response, you commit to retraining your microbiology staff to require microorganism identification, as well as accurate and contemporaneous recording of CGMP activities.Your response is inadequate in that you do not adequately address the major flaws in your laboratory system. Your response also lacks steps to systemically address your inadequate oversight of data integrity, including but not limited to improving your quality-assurance function.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, analyst competencies, and management oversight. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.Your(b)(4)often result in high counts, ranging from(b)(4)CFUs/(b)(4)mL. Explain how your firm characterizes these counts and define when you would deem a sample result to be Too Numerous To Count (TNTC). Also describe how your method ensures accurate and precise expression of test results in a “per ml” measurement.A complete, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, and contemporaneous records throughout your operation.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data-integrity practices at https://www.fda.gov/media/119267/download.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including all microbial-results data pertaining to drugs distributed to the United States. Include a detailed description of the scope and root causes of your data-integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective-action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act (21 U.S.C. 321(i)). Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1410794 and ATTN: Carlos Gonzalez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research