ASP Global, LLC. dba Anatomy Supply Partners, LLC.（CMS # 718444）

WARNING LETTER
CMS # 718444

December 9, 2025

Dear Mr. Shaver:

During an inspection of your firm located in Austell, Georgia from July 28, 2025, through August 1, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Safe-T-Fill Micro Capillary Collection 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 Violations
This 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 Tracy A. Weldon, Vice President of Quality and Regulatory dated August 22, 2025, 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 adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. Your firm failed to adequately implement supplier management procedures to ensure that products purchased from your critical supplier and manufacturer of Safe-T-Fill Capillary Collection Tubes, (b)(4), conform to specified requirements.

For example, your supplier management procedures were not adequately implemented to ensure that product purchased from critical supplier and manufacturer of Safe-T-Fill Capillary Collection Tubes, (b)(4), provided product that conform to specified requirements. Your firm did not verify the product’s ability to meet specified needs or (b)(4) ability to produce products that do not interfere with (b)(4) lead analyzers, a common lead testing technique. There were 26 complaints reported to ASP Global from October 2024 to April 2025 (Complaints 2024-01 through 2025-18) related to false positive lead results when Safe-T-Fill EDTA tubes were used with Magellan LeadCare systems. The ongoing investigation in CAPA-02 and SCAR-339 identified that (b)(4) uses (b)(4) versus (b)(4) to (b)(4) the capillary tubes, and (b)(4) may contain higher levels of (b)(4) impurities from the (b)(4). The investigation noted that (b)(4) behaves similarly to lead when using (b)(4), which is used by the Magellan LeadCare systems, causing false positive results. Your firm’s procedure "Supplier Management", Q-P-035, Rev. 3, 08/01/2022, Section 3.1 states, "The purpose is to ensure that ASP Global’s suppliers are selected, qualified, approved, and monitored based upon risk-based practices and regulatory requirements to ensure consistent final product quality through the utilization of qualified suppliers and agreed upon requirements and/or specifications." The following deficiencies were noted during our inspection,

A. (b)(4) supplier evaluations using Form Q-F-256 were not performed for (b)(4) in (b)(4) and (b)(4) as required. Section 10.4.4.1 of the Supplier Management SOP requires "Supplier Evaluations are conducted for Tier (b)(4) suppliers once every (b)(4)... Q-F-256 On-Going Supplier Evaluation Form is used to document the supplier evaluation."

B. An on-site audit of (b)(4) was not performed in (b)(4) as required, with no documented justification provided. Additionally, multiple other Tier (b)(4) suppliers were not audited on the required (b)(4). The Supplier Management SOP, Q-P-035, Rev. 3, Section 10.5.3.1 states "Tier (b)(4) contract manufacturers of finished devices to (b)(4) specifications require on-site audits at a minimum of once every (b)(4) unless otherwise specified."

C. (b)(4) was audited by FDA in (b)(4) and received four observations, but ASP Global was not notified until April 29, 2025, after (b)(4) was placed on Import Alert, despite working closely with (b)(4) on SCAR-339 from February to March 2025. The ASP/(b)(4) Quality Agreement, Section 2.3, Page 6 of 15, states "(b)(4) shall notify ASP in writing within (b)(4) if any of the following occurs: (c) (b)(4) becomes aware of any inspection or audit findings that affect safety, effectiveness, conformity, or availability of product."

D. ASP Global did not verify that (b)(4) maintains adequate design history files (DHF) for the Safe-T-Fill products during the supplier evaluation period (12/2022) following the acquisition of 510(k)’s K981973 and K983517 from (b)(4). The Quality Agreement states in Section 2.2 that "(b)(4) will maintain 'Design History Files' with all design inputs, outputs and changes," but ASP Global was unable to provide the full DHF during the inspection due to deficiencies noted during (b)(4) FDA inspection.

E. ASP Global did not review Safe-T-Fill product information to determine if specifications adhered to original 510(k) clearances or if a new 510(k) was required for changes to the originally cleared products. The 300 μL size Safe-T-Fill tubes have been marketed since 2001 without proper evaluation of whether a new 510(k) clearance is required, as only 125 μL, 150 μL, and 200 μL tubes were cleared in the original 510(k)s K981973 and K983517 in 1998. Product catalogs and labels show 300 μL tubes being actively marketed.

Your firm’s failure to have adequate purchasing controls to include design controls for the Safe-T-Fill product demonstrates significant deficiencies in the design and manufacture of these products. The distribution of device without appropriate design controls throughout the product development lifecycle may pose patient safety risks and potentially lead to inappropriate medical interventions.

Your firm's responses dated August 22, 2025, and October 22, 2025, are inadequate. Your firm's commitment to implementing corrective actions is acknowledged; however, the response does not include adequate details and supporting documentation regarding ongoing corrective actions. Your response lacks sufficient detail and documentation for the following proposed corrective actions: (1) development of effectively implemented supplier controls based upon supplier history and product risk assessment, (2) ensuring suppliers are managed by adequately trained and resourced personnel, (3) development of meaningful audit criteria and schedules for conducting periodic audits of appropriately identified Tier (b)(4) suppliers, (4) development of robust integration procedures to properly assess firms during integration for compliance with all regulatory requirements, including legacy product changes and associated clearances, (5) development of procedures to properly evaluate and audit suppliers once acquired, and (6) ensuring creation of necessary work instructions to ensure proper adherence to new and existing procedures.

While your response includes a revision of the (b)(4) Supplier Quality Agreement (SQA) to require design verification, design validation, risk management, and design transfer, you have not provided sufficient detail or records regarding implementation of these corrective actions. As the owner of the SAFE-T-FILL tubes associated with 510(k) numbers K981973 and K983517, you have not demonstrated how these corrective actions will ensure compliance with all requirements under 21 CFR 820.30. The SAFE-T-FILL Capillary Blood Collection System is indicated for drawing blood via capillary action from finger or heel stick placement in a microtube for obtaining blood samples for diagnostic testing. Lead testing represents one of many common laboratory tests performed in clinical laboratories.

Your response fails to describe how you will remediate design control records, including the design history file (DHF), to ensure that critical specifications for your firm's SAFE-T-FILL Capillary Blood Collection System cleared 510(k)s meet user needs and the intended use of the device. Your response notes that (b)(4) has been disqualified as a supplier; however, it remains unclear how they will provide supplied services such as design control remediation activities as part of your firm's corrective action plan to FDA 483 Inspection Observations. In addition, your response does not describe how these deficiencies impact other supplied product contract manufacturered and designed by (b)(4) such as SAFE-T-FILL Capillary Blood Collection System; Plasma – Chemistry; Serum – Chemistry, Glucose only; Serum – Chemistry; Blood Gas Capillary Tubes; Micro Hematocrit Tubes and other SAFE-T-FILL Capillary Blood Collection System accessories. Therefore, it does not appear you have properly evaluated (b)(4) on their ability to meet specified requirements.

Your response does not address any assessment or review of purchased medical products such as class II medical devices that are further distributed by ASP Global and whether these products continue meet the original market clearance or if substantial changes have been made that require a new 510(k) submission.

Medical Device Reporting (MDR) Violations
Our inspection also revealed that your firm’s Safe-T-Fill Micro Capillary collection system devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

2. Failure to adequately develop, maintain, and implement written MDR procedures as
required by 21 CFR 803.17(a)(3). For example, during the inspection, your firm presented your documents titled “Reports-Medical Device, Vigilance and Foreign Regulatory Agency”, Document# Q-P-25, Rev. 2, dated 06/17/21, and “Definitions”, Document# Q-P-067, Rev. 0, dated 08/03/2021. After collectively reviewing them as your firm’s written MDR procedure, it was noted that the procedure Q-P-25, Rev. 2, does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, Section 6.2 references a reporting timeframe for initial (b)(4) reports; however, it incorrectly specifies instructions pertaining to (b)(4) reports.

Additionally, Section 6.3.5 of the procedure Q-P-25, Rev. 2, includes references to baseline reports. Baseline reports are no longer required, and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure; see: 73 Federal Register Notice 53686, dated September 11, 2008.

The adequacy of your firm’s responses dated August 22, 2025, and October 22, 2025, cannot be determined at this time as various corrective actions remain ongoing. Your responses note that your firm has revised procedure Q-SOP-0031, (Reports – Medical Device, Vigilance and Foreign Regulatory Agency), and Q-Form-0045, (US Complaint Reportability Decision Tree), and that training on them is underway. You have also noted that you are in the process of revising Q-SOP-0030, Rev 3, (Complaints procedure) to include roles and responsibilities for complaint receipt, evaluation, investigation, and reporting. Additionally, you have stated that you will align Q-P-067, Rev 0 (Definitions) with the revised Q-SOP-0031, Rev 3 to ensure procedural consistency. You have indicated that personnel training will be completed (b)(4) implementation of the procedure. Finally, you have indicated that you are in the process of performing a retrospective review of complaints to address late reporting and will submit MDRs as needed.

Corrections and Removals Violations
Our inspection also revealed that your firm’s Safe-T-Fill Micro Capillary Collection System devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

3. Failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Act caused by the device which may present a risk to health, as required by 21 CFR 806.10(a). For example:

On April 24, 2025, FDA issued a Safety Alert identifying the possibility of false positive lead results when using Safe-T-Fill Micro Capillary Collection Tubes with Magellan LeadCare Systems. The Safety Alert recommended not using these products together due to health risks.

The inspection noted that ASP received complaints with multiple reports of falsely elevated blood lead level results when the Safe-T-Fill Micro Capillary Blood Collection Tubes were used with Magellan LeadCare test systems. On May 5, 2025, ASP Global sent correspondence to all Safe-T-Fill customers notifying them of the FDA Safety Notice. On May 16, 2025, ASP Global sent an updated communication instructing customers to follow the FDA Safety Alert and announcing that as of May 12, 2025, all sales of Safe-T-Fill Micro Capillary Blood Collection Tubes were being placed on hold until further notice.

These actions constituted a correction under 21 CFR 806.2(d), as they involved modification or adjustment of device use without physical removal from the point of use to reduce a risk to health. The use of Safe-T-Fill tubes with Magellan LeadCare systems presents a risk to health, as false positive lead results prompt unnecessary confirmatory venous blood draws in primarily pediatric patients, potentially delaying accurate diagnosis and leading to improper patient management. As of the date of the FDA inspection, ASP Global failed to report this correction to FDA within 10 working days of initiation as required by 21 CFR 806.10(a)(1)(b) despite the risk to health posed by continued use of the devices with Magellan LeadCare systems and your firm's own actions to address this risk through customer communications and product hold.

Your firm submitted Report of Correction or Removal number: 3004824601/08212025/R/00001 to FDA on or around September 8, 2025. This report remedies your firm’s failure to submit a Report of Correction or Removal to FDA. We also note, however, that your response dated August 22, 2025, promised to update SOP# Q-SOP-0030, Rev 3, Complaints procedure to ensure proper escalation from a quality event or trend in post market data to CAPA and HHE based on the degree of potential patient impact. This prompts the recall determination process to engage management so that appropriate actions can be initiated in a timely manner. This is targeted for completion November 2025. Completion of these tasks would support the assertion that future medical device corrections or removals will be appropriately reported to FDA.

Unapproved Device Violations
Our inspection also revealed that the EDTA Mini Capillary Collection Tube 125 μL Self-Sealing((b)(4)), EDTA Capillary Collection Tube 200 μL Self-Sealing ((b)(4)), EDTA Capillary Collection Tube 300 μL ((b)(4)), Lithium Heparin Capillary Collection 300 μL ((b)(4)), Lithium Heparin Bilirubin Capillary Collection 200 μL ((b)(4)), Serum Capillary Collection Tube 300 μL ((b)(4)), and Serum Gel Capillary Collection 300 μL ((b)(4)) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications in the device without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).

4. Specifically, based on review of evidence found during the inspection, your firm has made significant changes or modifications to the original devices, the SAFE-T-FILL Capillary Collection System that were cleared under K981973 and K983517, for which your firm lacks clearance or approval. Examples include:

A. For the modifications to increase the sample volume from 200 μL to 300 μL for products (b)(4), the change could introduce potential preanalytical errors associated with the specimen collection process. Higher blood volume requirement may also be more difficult in pediatric patients and any underfill specimen could introduce the risk of changing the ratio of anticoagulant to blood volume. An increase in volume requirement could also result in increased hemolysis if the users “milk/squeeze” from the source (e.g. fingers and/or heels) in order to collect more blood. Hemolysis is known to cause erroneous results in downstream laboratory tests.

B. For the modifications to increase the sample volume from 200 μL to 300 μL of blood collection tubes that contain additives such as for products (b)(4) (contains liquid dipotassium EDTA) and product (b)(4) (contains lithium heparin), it is unclear if your firm has maintained the same additive-to-blood volume ratio in the 300 μL tubes compared to the 200 μL tubes. If the anti-coagulant concentration is changed, the timing and/or completeness of the clotting process will likely change. This can affect the sample quality and result in inaccurate test results.

C. FDA noted that your firm has introduced product (b)(4) Lithium Heparin Bilirubin Capillary Collection 200 μL to the market. In both of your firm’s 510(k) submissions, FDA cleared several serum capillary collection tubes but not any plasma capillary collection tubes for the purpose of downstream bilirubin testing. The change from serum to plasma represents a new sample type and included the addition of lithium heparin, an additive that was not present in the original clearance and which could cause erroneous results in the downstream bilirubin testing.

D. Your firm also introduced the self-sealing versions of product numbers (b)(4) and (b)(4) (to become products (b)(4) and (b)(4) respectively). The introduction of self-sealing likely requires new components/materials used to make the tubes or the stopper. Any new components or materials could potentially affect performance of downstream laboratory testing if the different materials for the tube or stopper leach substances that could interfere with downstream laboratory tests. Additionally, any leakage of blood (if the tubes did not seal appropriately as intended) pose a risk of exposure to bloodborne pathogens. Finally, new materials used in the self-sealing tubes should meet the shelf-life stability throughout the claimed shelf-life originally cleared.

These changes represent significant modifications to the SAFE-T-FILL Capillary Collection System that were cleared in the original 510(k)s that could significantly affect the safety or effectiveness of the device. Therefore, submission of a new premarket notification under section 510(k) is required. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at How to Study and Market Your Device | FDA The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

The adequacy of your firm’s responses dated August 22, 2025, and October 22, 2025, cannot be determined at this time. Your responses stated that you have stopped shipping all SAFE-T-FILL products as of May 12, 2025, and have made the decision to remove all SAFE-T-FILL Micro Capillary Blood Collection Tube products from U.S. commercial distribution due to the significant GMP violations documented in FDA’s May 2025 Warning Letter issued to Kabe. Before these products return to the market, you will conduct thorough regulatory assessments and will obtain any necessary clearance through the 510(k) process for any models that you have assessed are not covered by the original 510(k) clearances. Your firm added that there is no final decision or timeline for resuming commercialization of SAFE-T-FILL Capillary Tubes as of the October 22, 2025, response date. Your firm should provide a copy of your regulatory assessment and plans to seek new 510(k) clearances before resuming commercialization of the tubes for review.

Labeling Violations

5. The inspection also revealed that Micro Capillary Blood Collection - 125 μL (b)(4), Micro Capillary Blood Collection - 150 μL (b)(4), Micro Capillary Blood Collection - 200 μL (b)(4) and Micro Capillary Blood Collection - 200 μL Flat Bottom (b)(4) are misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f) in that labeling fails to bear adequate directions for use. These devices do not meet the criteria for an exemption from section 502(f)(1) of the Act under 21 CFR 801 subpart D. Title 21 CFR 801.119 expressly exempts in vitro diagnostic products from section 502(f)(1) of the Act if, among other things, the device meets the requirements of 21 CFR 809.10.

A. The labeling does not contain the intended use statement of the product pursuant to 21 CFR 809.10(b)(2).

B. The labeling does not provide adequate descriptions of specimen collection (per 809.10(b)(7)) and does not contain a list of all materials provided, a list of materials required but not provided and times required for specific steps and proper temperature, etc. as required by 809.10(b)(8)(i) – (iii). The labeling also does not contain limitation of the procedures (per 809.10(b)(10)), bibliography section (per 809.10(b)(13)) and the date of issuance of the last revision of the labeling identified as such (per 809.10(b)(15)).

C. The label and labeling do not contain the name and place of business of manufacturer, packer, or distributor as required by 21 CFR 809.10(a)(8) and (b)(14). The inner box label, inner carton label, and case label reflect (b)(4) which is the name, city, state, and zip code for the previous 510(k) holder and manufacturer for the SAFE-T-FILL Tubes. The package insert lacks any name and place of business .

The adequacy of your firm’s responses dated August 22, 2025, and October 22, 2025, cannot be determined at this time. Your firm opened CAPA-000008 to address Discussion item 2. Your firm stated that you did not adequately review the labeling received from (b)(4) in 2022 against the labeling submitted in the original 510(k)s or the requirements in 21 CFR 809.10. Your firm stated that you have implemented a shipping hold on all SAFE-T-FILL product in your possession on May 12, 2025, and have begun a recall all in date products already distributed in the US due to the quality system violations found at (b)(4). Your firm has submitted 806 reports notifying FDA of this removal. Before reintroducing the SAFE-T-Fill products to the market you plan to evaluate all labeling and provide copies for review as appropriate.

Your response also stated that you plan to develop procedures for review of acquired devices against applicable regulatory requirements and procedures for labeling review by December 15, 2025 and provide training by January 12, 2026. Your firm plans to conduct a retrospective review and remediation of labeling for all devices owned by ASP by March 27, 2026. Your response stated that you plan to provide details of these actions in a future response. As part of your firm’s corrective action, you should provide updated device labeling that meets all applicable requirements under 21 CFR 809.10 for review.

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, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 718444” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla, Compliance Officer 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. Marsden
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health