Delivery Method:VIA UPS and Electronic MailReference #:CBER 26-722459Product:BiologicsRecipient:Dr. Derek A. HaasMedical DirectorConceive Fertility Center7515 Greenville Ave Ste 1030Dallas,TX75231United Statesdrhaas@cfcivf.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERCBER 26-722459January 27, 2026Dear Dr. Haas:During an inspection of your firm, Conceive Fertility Center located at 7515 Greenville Ave Ste 1030, Dallas, TX 75231, conducted between June 6, 2025, and June 13, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (21 CFR) Part 1271 [21 CFR 1271] and issued under the authority of Section 361 of the Public Health Service Act [42 U.S.C. § 264].The observations documented on the Form FDA-483, List of Inspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection, and following FDA’s review, your violations include, but are not limited to, the following:1) Failure to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for and clinical evidence of relevant communicable disease agents and diseases [21 CFR 1271.75(a)(1)]. Your firm’sDonor Medical History Interview Formis used as a relevant medical record to determine donor eligibility. From January 1, 2022, through June 12, 2025, your firm used this form to screen approximately 61 anonymous oocyte donors, 40 directed oocyte donors, and 79 directed semen donors. However, your form does not include screening for all conditions and/or behaviors that increase a donor’s relevant communicable disease risk. The form is missing questions, timeframes, and/or deferral periods to assess a donor’s relevant communicable disease risk:a. Question 5 states, “Have you had sex in the preceding 12 months with any person described in the previous 4 items in this section or with any person known or suspected to have HIV infection, clinically active hepatitis B infection, or hepatitis C infection?” To adequately and appropriately reduce the risk of transmission of these diseases, the question needs to ask about hepatitis B infection (both active and inactive) and clinically active (symptomatic) hepatitis C infection.b. Question 8 states, “Have you had close contact within 12 months preceding donation with another person having clinically active viral hepatitis (e.g., living in the same household, where sharing of kitchen and bathroom facilities occurs regularly)?” The question needs to ask whether persons have lived with (resided in the same dwelling) another person who hashepatitis Borclinically active (symptomatic) hepatitis C infectionin the preceding 12 months.c. Question 9 states, “Have you had a tattoo or body piercing in the last 12 months in which instruments were shared?” The question needs to also ask whether sterile procedures were not used.d. Persons who have had a medical diagnosis orsuspicionof West Nile Virus (based on symptoms and/or laboratory results or confirmed WNV viremia) need to be deferred for120 daysfollowing diagnosis or onset of illness, whichever is later. You do not include “suspicion” in your form or equivalent terminology to adequately screen for this illness.e. Your form fails to screen for persons who have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.f. Your form fails to screen for persons who have been treated for or had syphilis within the preceding 12 months.g. Your form fails to adequately screen for persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or morecumulativelyfrom 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or morecumulativelyfrom 1980 through 1996. Without “cumulatively” or similar language the question is under-inclusive.h. Your form fails to screen for persons who have received any transfusion of blood or blood components in France between 1980 and the present.2) Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1), (b), or (c) [21 CFR 1271.75(d)]. For example:a. Directed semen donor(b)(6)answered "yes" to Question #26 on the Spanish version of the Donor Medical History Interview Form, “Have you lived cumulatively for 5 years or more in Europe from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996?" Donor(b)(6)was determined “eligible” on April 30, 2025.b. Directed semen donor(b)(6)answered "yes" to Question #1 on the Donor Medical History Interview Form, "(Men Only) Have you had sex with another man in the preceding five years?" Donor(b)(6)was determined “eligible” on April 12, 2024.3) Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 21 CFR 1271.80 and 21 CFR 1271.85 [21 CFR 1271.50(a)]. The eligibility of donors was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents. For example:a. Directed oocyte donor(b)(6)was determined “eligible” on February 20, 2025, but the results of donor testing were not received until February 22, 2025.b. Anonymous oocyte donor(b)(6), Donor(b)(6)was determined “eligible” on September 28, 2024, but the results of donor testing were not received until September 30, 2024.4) Failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor; or up to seven days before or after recovery [21 CFR 1271.80(b)]. For example,a. Semen was collected from directed donor(b)(6)on(b)(6). However, a specimen for communicable disease testing was collected from the donor on(b)(6). Donor(b)(6)was determined “eligible” on December 19, 2024.b. Semen was collected from directed donor(b)(6)on(b)(6). However, a specimen for communicable disease testing was collected from the donor on(b)(6). Donor(b)(6)was determined “ineligible” on October 2, 2023.5) Failure to include in the summary of records a statement noting the reason(s) for the determination of ineligibility in the case of an HCT/P from a donor who is ineligible based on screening and released under 21 CFR 1271.65(b) [21 CFR 1271.55(b)(4)]. For example, a review of the donor records collected during the inspection, revealed that at least 21 directed semen donors were determined “ineligible”, however, the summary of records does not state the reason for the determination of ineligibility.6) Failure of the summary of records, required under 1271.55(a)(3), to contain a listing and interpretation of the results of all communicable disease tests performed [21 CFR 1271.55(b)(2)]. For example, yourSUMMARY OFRECORDS/DONOR ELIGIBILITY DETERMINATION- DONORform does not include a listing and interpretation of the results of specific testing for anti-HIV-1,anti-HIV-2, HIV-1 NAT, HBV NAT, HCV NAT, WNV NAT, anti-HTLV I/II, and anti-CMV (total IgG and IgM).7) Failure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part 1271.45-1271.90.“Establish and maintain” means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. For example, your Standard Operating Procedure (SOP),Office Screening of Patients Donating Human Cells (Oocytes and Sperm), does not contain donor eligibility procedures describing requirements that must be met to determine a donor as eligible or ineligible. We note that this is a repeat violation that was discussed with your firm during the FDA inspection conducted between October13, 2021, and October 15, 2021.The violations identified above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment complies with all applicable federal regulations. You are responsible for reviewing your firm’s operations, including firms within the same organization, as a whole to ensure that you are in compliance with the law.We acknowledge receipt of your letter, dated June 24, 2025, providing a response to FDA’s inspectional observations. We have reviewed your response, and we have determined that the response is inadequate to address our concerns. We have the following comments regarding your FDA 483 response:1) Regarding Observation 2, your response did not address whether there are HCT/Ps still in storage from donors that were not screened and/or tested in accordance with 21 CFR 1271.2) Regarding Observation 3, we acknowledge the implementation of your new SOP,Screening and Eligibility Determination for Sperm Donors Regarding Cytomegalovirus (CMV)(Effective Date: 06/17/2025). However, the SOP does not include how the CMV test results will be communicated to the physician responsible for accepting the HCT/P so that they may rely on the information to make informed decisions about the use of an HCT/P in a particular recipient's situation.3) Regarding Observation 4, we acknowledge your revision to SOP,Office Screening of Patients Donating Human Cells (Oocytes and Sperm)(Revised Date: 06/24/2025), to include requirements that must be met to determine a donor as eligible or ineligible and departures from procedures. Our review of your procedure found the following:a. Your procedure does not specify anti-HBc and WNV NAT as required testing.b. Section 3, “Medical History Evaluation,” states that if donors respond “yes” to a question on your Donor Medical History Interview Form (DMHIF), “Further investigation with laboratory testing may be needed before the physician determines the patient can be considered eligible to donate tissue.” Section 6, “Donor Eligibility Determination,” states that if donors respond “yes” to a question on your DMHIF, and “… it is determined that the risk of a communicable disease is negligible, the donor may still pass.” In accordance with 21 CFR 1271.75(d)(1), a donor who is identified as having a risk factor for or clinical evidence of any of the relevant communicable disease agents or diseases for which screening is required under paragraphs (a)(1), (b), or (c) must be determined to be ineligible. This applies to both anonymous and directed donors.c. Section 6, “Donor Eligibility Determination,” regarding test results states, “If any of the testing is positive, a provider must determine if there is an active infection (donor would be ineligible in that case), or if there is a previously treated infection that continues to show positive for the test in question.” In accordance with 21 CFR 1271.80(d)(1), a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with 21 CFR 1271.85, except for a donor whose specimen tests reactive on a non-treponemal screening test for syphilis and negative on a specific treponemal confirmatory test, must be determined to be ineligible. This applies to both anonymous and directed donors.d. Section 6, “Donor Eligibility Determination,” allows for donors who test reactive forChlamydia trachomatisorNeisseria gonorrheato be reconsidered with a negative test-of-cure and a 3-month waiting period after completion of treatment. However, evidence needs to be presented that the treatment occurred more than 12 months ago and was successful.Finally, we have the following additional comments regarding your firm's operations:Section 6 of your SOP,Office Screening of Patients Donating Human Cells (Oocytes and Sperm)(Revised Date: 06/24/2025), states that the “Summary of Records/Donor Eligibility Determination Form” is completed with the “Eligible” or “Ineligible” status. There are two locations on this form where your firm documents and dates the donor eligibility determination. The dates do not match for multiple donors.Sections III (ELIGIBILITY) and IV (LABELING) of the “Summary of Records/Donor Eligibility Determination Form” includes checkboxes for “ELIGIBLE.” However, “ELIGIBLE” was also checked under Section IV for several directed donors who were determined “INELIGIBLE” under Section III. In addition, the symbols listed in Section IV do not include the Biohazard legend shown in 21 CFR 1271.3(h).Additional information regarding the regulation of HCT/Ps is available at:https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-productshttps://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidancesFDA Workshop for the Reproductive Tissue Industry - Sept 29 and Oct 1, 2020 - 09/29/2020 - 10/01/2020 | FDAPlease note that if you still have oocytes and/or semen in storage from donors whose screening and/or testing was not completed in accordance with 21 CFR Part 1271, FDA considers the donor eligibility determinations to be incomplete for these donors. For example, this includes donors who were not appropriately tested for relevant communicable disease agents and diseases and/or who were not appropriately screened for relevant communicable disease risk factors which includes using previous versions of donor history questionnaires (e.g., non-English versions) that did not screen for all conditions and/or behaviors that increase a donor’s relevant communicable disease risk. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine.Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may request an exemption or alternative from a requirement in Subpart C, 21 CFR Part 1271, as specified in 21 CFR 1271.155. Additional information can be found at Exemptions and Alternatives | FDA. The email address for submissions is HCTPExemptions@fda.hhs.gov.Please note that 21 CFR 1271.155 requires that you provide justification for use of HCT/Ps from these donors, as well as information on how you have mitigated the risk consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases. Before any of these HCT/Ps can be removed from quarantine, the request must be granted by FDA.If you still have embryos in storage for which the donor eligibility requirements under 21 CFR 1271, Subpart C are not met, please note that FDA considers the donor eligibility determinations to be incomplete for these donors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine. Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may release these HCT/Ps from quarantine [21 CFR 1271.90(b)] provided they are labeled in accordance with the applicable regulations at 21 CFR 1271.90(c).You should take prompt action to correct any violations addressed in this letter and prevent their recurrence. Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent them, or similar violations, from occurring again. Additionally, include any documentation necessary to show that correction has been achieved. If you believe that your products are not in violation of the law, include your reasoning and any supporting information for our consideration. If you cannot complete all corrective actions within fifteen (15) working days, please explain the reason for your delay and the timeframe within which the remaining corrections will be completed.Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.If you have any questions regarding this letter, please contact CBER’s Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via UPS and EMAILReference #:CBER 26-722521Product:BiologicsRecipient:Edward J. Ramirez, MD, FACOGExecutive Medical DirectorCentral Coast Multispecialty Medical Group, Inc.9833 Blue Larkspur LnMonterey,CA93940United Statesejrmd@montereybayivf.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERCBER 26-722521January 29, 2026Dear Dr. Ramirez:During an inspection of your firm, Central Coast Multispecialty Medical Group, Inc., located at 9833 Blue Larkspur Lane, Monterey, CA, conducted between May 13, 2025, and May 16, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (21 CFR) Part 1271 [21 CFR 1271] and issued under the authority of Section 361 of the Public Health Service Act [42 U.S.C. § 264].The observations documented on the Form FDA-483, List of Inspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection, and following FDA’s review, your violations include, but are not limited to, the following:1) Failure to screen a donor of reproductive cells or tissue by reviewing the donor’srelevant medical records for risk factors for, and clinical evidence of, relevantcommunicable disease agents and diseases [21 CFR 1271.75(a)(1)]. Your firm’sDonor Eligibility Questionnaire and Donor Medical History Interview Form areused as relevant medical records to determine donor eligibility. However, yourforms do not include screening for all conditions and/or behaviors that increase adonor’s relevant communicable disease risk. For example, the Donor EligibilityQuestionnaire form submitted with your FDA 483 response is missing questions,timeframes, and/or deferral periods to assess a donor’s relevant communicabledisease risk for the following:a. Question 5 fails to screen for persons who have had sex in the preceding 12 months with any person who has had sex with a man who has had sex with another man in the preceding 5 years, persons withhepatitis B infection(both active and inactive) orclinically active (symptomatic)hepatitis C infection, persons who have injected drugs for a non-medical reason in the preceding 5 years, including intravenous, intramuscular, or subcutaneous injections, and persons who have engaged in sex in exchange for money or drugs in the preceding 5 years.b. Question 8 states, “Have you within the past 12 months of donation undergone tattoing [sic], ear piercing, or body piercing in which shared instruments are known to have been used.” The question needs to also ask whether sterile procedures were not used.c. Question 11 states, “Have you had a recent smallpox vaccination (vaccinia virus) in the last 21 days?” To adequately and appropriately reduce the risk of transmission of this disease, the question needs to ask about smallpox vaccination (vaccinia virus) in the preceding8 weeks.d. Question 13 states, “Have you had a medical diagnosis of West Nile Virus Infection within the last 120 days (including diagnosis based on symptoms and laboratory results, or confirmed WNV viremia)?” You do not include “suspicion” in your form or equivalent terminology to adequately screen for this illness.e. Your form fails to adequately screen for persons who have spent 3 months or morecumulativelyin the UK between 1980 and 1996. Without “cumulatively” or similar language the question is under-inclusive.f. Your form fails to adequately screen for persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or morecumulativelyfrom 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or morecumulativelyfrom 1980 through 1996. Without “cumulatively” or similar language the question is under-inclusive.g. Your form fails to screen for persons who spent 5 years or more cumulatively in Europe from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996).h. Your question 29 states, “Have you had close contact within 12 months preceding donation with another person having clinically active viral hepatitis?” To adequately and appropriately reduce the risk of transmission of this disease, the question needs to also ask about persons who have lived with (resided in the same dwelling) another person who hashepatitis Borclinically active (symptomatic) hepatitis Cinfection in the preceding 12 months.i. Your form fails to screen for persons who have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.2) Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1), (b), or (c) [21 CFR 1271.75(d)]. For example, directed semen donor(b)(6)answered "yes" to question 1 on yourDonor Medical History Interview Form, “(Men only) Have you had sex with another man in the preceding five years?” Donor(b)(6)was determined “eligible” on May 9, 2025.3) Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 21 CFR 1271.80 and 21 CFR 1271.85 [21 CFR 1271.50(a)]. The eligibility of donor(b)(6)was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents. For example, directed semen donor(b)(6)was determined “eligible” on May 9, 2025, but the results of donor testing forChlamydia trachomatis,Neisseria gonorrhea, and HIV/HCV/HBV NAT were not received until May 10, 2025.The violations identified above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment complies with all applicable federal regulations. You are responsible for reviewing your firm’s operations, including firms within the same organization, as a whole to ensure that you are in compliance with the law.Additional information regarding the regulation of HCT/Ps is available at:https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-productshttps://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidancesFDA Workshop for the Reproductive Tissue Industry - Sept 29 and Oct 1, 2020 - 09/29/2020 - 10/01/2020 | FDAWe acknowledge receipt of your letter, dated May 28, 2025, providing a response to the FDA’s inspectional observations. We have reviewed your response, and we have determined that the response is inadequate to address our concerns. We have the following comments regarding your FDA 483 response:1) We acknowledge the revisions made to your Donor Eligibility Questionnaire submitted with your response. However, our review of this questionnaire identified additional deficiencies as outlined in this letter.2) Regarding Observations 1 and 2, your response does not address the required labeling in accordance with 21 CFR 1271.65(b)(2). All donors, except as provided under 21 CFR 1271.90, are required to be screened by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases (21 CFR 1271.75(a)) and tested for relevant communicable diseases (21 CFR 1271.80). Please note, an HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, is not prohibited by Subpart C from use for implantation, transplantation, infusion, or transfer if the HCT/P consists of reproductive cells or tissue from a directed reproductive donor as defined in 21 CFR 1271.3(l).3) Regarding Observation 3, you stated “The policies and procedures that are in place in regards to our treatment of Donor patients is verbally transmitted through training and continuous guidance, and we do not rely on the Donor policy book for reference or use. It is merely there to be compliant.” Please be advised, you must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of 21 CFR Part 1271, Subpart C. Establish and maintain means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis.Please note that if you still have oocytes and/or semen in storage from donors whose screening and/or testing was not completed in accordance with 21 CFR Part 1271, FDA considers the donor eligibility determinations to be incomplete for these donors. For example, this includes donors who were not appropriately tested for relevant communicable disease agents and diseases and/or who were not appropriately screened for relevant communicable disease risk factors which includes using previous versions of donor history questionnaires that did not screen for all conditions and/or behaviors that increase a donor’s relevant communicable disease risk. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine.Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may request an exemption or alternative from a requirement in Subpart C, 21 CFR Part 1271, as specified in 21 CFR 1271.155. Additional information can be found at Exemptions and Alternatives | FDA. The email address for submissions is HCTPExemptions@fda.hhs.gov.Please note that 21 CFR 1271.155 requires that you provide justification for use of HCT/Ps from these donors, as well as information on how you have mitigated the risk consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases. Before any of these HCT/Ps can be removed from quarantine, the request must be granted by FDA.If you still have embryos in storage for which the donor eligibility requirements under 21 CFR 1271, Subpart C are not met, please note that FDA considers the donor eligibility determinations to be incomplete for these donors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine. Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may release these HCT/Ps from quarantine [21 CFR 1271.90(b)] provided they are labeled in accordance with the applicable regulations at 21 CFR 1271.90(c).You should take prompt action to correct any violations addressed in this letter and prevent their recurrence. Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent them, or similar violations, from occurring again. Additionally, include any documentation necessary to show that correction has been achieved. If you believe that your products are not in violation of the law, include your reasoning and any supporting information for our consideration. If you cannot complete all corrective actions within fifteen (15) working days, please explain the reason for your delay and the timeframe within which the remaining corrections will be completed.Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.If you have any questions regarding this letter, please contact CBER’s Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via EmailProduct:DrugsRecipient:James Nabors IIIManagerBeach Weekend Management LLC dba Nic and Jet Fuel119 Hollywood Blvd NW Ste 206Fort Walton Beach,FL32548-4758United Statesbrett@beachweekend.comhello@nicandjetfuel.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 5, 2026RE: 719715Dear James Nabors III:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://nicandjetfuel.com/ in November 2025. The FDA has observed that your website offers “Nicotina Energy Citrus Surge Lite 3 MG” and “Nicotina Energy Grapefruit Spark Lite 3 MG” for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Based on a review of your website, your “Nicotina Energy Citrus Surge Lite 3 MG” and “Nicotina Energy Grapefruit Spark Lite 3 MG” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:On the webpage https://nicandjetfuel.com/https://supplycenterusa.com/:• “Sparks Focus + Clarity . . . cut through mental clutter . . . help you zone in on what matters.”• “Boosts Dopamine . . . tap into your brain’s dopamine system, enhancing motivation, drive, and satisfaction.”• “Heightens Alertness[.] Nicotine activates pathways in the brain that sharpen reaction time and sensory awareness.”• “Elevates Mood . . . stimulates receptors tied to mood regulation”On a July 26, 2025 blog post: “Nicotine Energy Drinks: The Bold New Category You’ve Never Tried (But Should)” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/nicotine-energy-drinks-the-bold-new-category:• “What Are Nicotine Energy Drinks? Nicotine energy drinks combine a small, controlled dose of nicotine (typically 3mg or 6mg) with other energizing compounds like caffeine, adaptogens, and clean nootropics. . . . This is clean fuel. Think sharper focus, calmer nerves, and sustained drive — without the crash.”• “Why Nicotine? . . .[I]solated nicotine . . . acts on the brain’s acetylcholine system, improving memory, attention, and reaction time.”• “The Benefits of Nicotine Energy Drinks[:] Mental clarity without the jitters[,] Sustained energy without crashes[,] Laser-sharp focus for hours”On a July 3, 2025 blog post: “The Surprising Truth About Nicotine: Benefits, Risks, and Smarter Use” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/the-surprising-truth-about-nicotine-benefits-risks-and-smarter-use:• “Nicotine triggers the release of dopamine, acetylcholine, norepinephrine, serotonin, and beta-endorphins. The result? Better focus, faster reaction time, improved memory, appetite suppression, and reduced anxiety.”• “The Benefits. . .o Brain Boosting: Enhances attention and memory, especially in tired or sleep-deprived states.o Neuroprotection: May reduce risk or progression of diseases like Parkinson's and Alzheimer's.o ADHD Support: Works similarly to stimulants like Adderall by increasing dopamine and norepinephrine.o Mood Regulation: May ease symptoms of depression and anxiety in some users.”On a July 26, 2025 blog post: “What Is a Nicotine Energy Drink? (And Why It’s Not What You Think)” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/what-is-a-nicotine-energy-drink:• “Nicotine by itself is not tobacco. Not smoke. Not combustion. And when used responsibly in low doses, research shows it may actually support:o Mental clarityo Reaction timeo Focus and memoryo Appetite control”• “How Nicotine Affects Energy and Performance[.] . . . nicotine works on acetylcholine pathways — the neurotransmitter responsible for focus, alertness, and learning.”On a July 23, 2025 blog post: “Nicotine in Moderation: A Tool, Not Taboo” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/nicotine-in-moderation-a-tool-not-taboo:• “What the Research Sayso When microdosed and used responsibly, nicotine may support several cognitive and functional benefits”• “Increased Focus & Attentiono Nicotine stimulates the release of acetylcholine and dopamine—two neurotransmitters linked to learning, memory, and focus. Several studies have found improved reaction times, attention span, and short-term memory in test subjects using small doses.”• “Mood Stabilizationo Low-dose nicotine has been observed to improve mood, particularly under stress. It can enhance the brain’s reward system without the overstimulation seen in traditional energy drinks or synthetic compounds.”Your “Nicotina Energy Citrus Surge Lite 3 MG” and “Nicotina Energy Grapefruit Spark Lite 3 MG” products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Furthermore, please note that if you take corrective actions such that your products are no longer drugs, your products may meet the definition of a tobacco product under section 201(rr)(1) of the FD&C Act and thus would be required to comply with the FD&C Act and its implementing regulations relating to tobacco products.1For instance, generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)). All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion including, but not limited to, civil money penalties, seizure, and/or injunction.In addition, products that meet the definition of a food under section 201(f) of the FD&C Act must comply with the requirements and prohibitions applicable to foods. Many substances intentionally added to beverages and other conventional foods are food additives. Food additives require premarket approval based on data demonstrating safety. Any unapproved food additive used in a beverage or other conventional food causes the food to be adulterated under section 402(a)(2)(C) of the FD&C Act. Adulterated foods cannot be legally imported or marketed in the United States.ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “719715” in the subject line of the email.Sincerely,/S/Jill P. FurmanDirectorOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration/S/John E. VerbetenDirectorOffice of Compliance and EnforcementCenter for Tobacco ProductsFood and Drug Administration_______________________1Note that section 201(rr)(2) of the FD&C Act provides that an article is not a tobacco product if it is a drug under section 201(g)(1).

Delivery Method:Via UPS and EMAILReference #:CBER 26-720762Product:BiologicsRecipient:Andreas Kogelnik, MD, PhDFounder & Chief Executive OfficerProDx Health1190 O'Brien DrMenlo Park,CA94025United Statessupport@prodxhealth.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERFebruary 10, 2026CBER 26-720762Dear Dr. Andreas Kogelnik:The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, ProDx Health, is offering for sale in the United States human immunodeficiency virus (HIV) serological diagnostic sample self-collection kits (hereinafter, your “sample self-collection kits”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1 Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your sample self-collection kits 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.FDA has reviewed your company’s website at https://prodxhealth.com (last visited February 2026) and your firm’s February 3, 2026 response to previous FDA correspondence. Based on our review of these materials, your firm offers its sample self-collection kits for delivery to individuals and intends for these individuals to use the kits to self-collect serological samples and ship those samples to laboratories for HIV testing. FDA has determined that your sample self-collection kits are adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because they do not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your sample self-collection kits are also misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the Agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k). FDA has not authorized your firm’s sample self-collection kits for use in HIV serological diagnostic testing. Notably, this letter focuses on your sample self-collection kits and is not intended to be a comprehensive list of potential issues with your firm’s products.Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your sample self-collection kits. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We note that there are FDA-approved over-the-counter HIV self-tests that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your sample self-collection kits. Your firm should take prompt action to address the 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.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your firm’s sample self-collection kits are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/s/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research1The letter FDA issued you on January 8, 2026, erroneously referred to your device as a “dried blood spot (DBS) card” self-collection kit. We have removed that letter from our website and are issuing this amended Warning Letter.

因药品经营许可证被吊销，依据《中华人民共和国行政许可法》第七十条第四款、《药品经营和使用质量监督管理办法》第二十七条第三款规定，决定注销重庆鼎瀚药业有限公司《药品经营许可证》。现将注销情况予以公告。　　附件：注销的许可证内容重庆市药品监督管理局2026年2月10日附件 注销的许可证内容 序号企业名称许可证名称许可证编号1重庆鼎瀚药业有限公司药品经营许可证渝AA023000020

新春佳节临近，美妆美发市场迎来消费高峰，选购美妆产品、装点节日形象成为广大市民的共同选择。近日，阳泉市市场监管局聚焦化妆品经营使用与消费安全，向全市化妆品经营使用主体、广大市民朋友发布安全提示，引导大家远离“美丽陷阱”，安心扮靓过大年。作为化妆品经营使用主体，经营者承载着为消费者提供安全、有效、合规产品的重任，阳泉市局对全市化妆品经营、使用单位提出四点明确要求，压实主体责任，规范经营行为。一是坚守法律底线，诚信合规经营。自觉遵守《化妆品监督管理条例》《化妆品生产经营监督管理办法》等法律法规，确保所售化妆品来源合法、质量可靠。依法亮照经营、公示资质信息，坚决抵制假冒伪劣、过期变质等违法违规行为。二是落实主体责任，严把质量关口。严格执行进货查验、索证索票、台账记录制度，对供应商资质、产品注册备案信息、检验合格证明等逐一审核并妥善留存。杜绝自行分装、灌装、配制化妆品，严禁擅自更改生产日期、限用日期等违规行为。积极向消费者公示产品成分、功效、使用方法及注意事项等信息，保障消费者知情权。三是规范经营行为，杜绝虚假宣传。遵循公平竞争原则，明码标价、诚信定价，杜绝价格欺诈、强制消费等损害消费者权益的行为。真实准确披露产品信息，不进行“快速美白”“根治色斑”等虚假夸大宣传，不宣称具有医疗功效，不使用医疗术语，不炒作伪科技概念。确保国产化妆品标签信息完整规范、进口化妆品加贴符合规定的中文标签。四是强化服务意识，践行社会责任。主动开展化妆品安全科普宣传，定期对从业人员进行化妆品法律法规、产品知识及职业道德等方面的培训，为消费者提供专业用妆指导。畅通消费沟通渠道，及时回应群众诉求，积极化解消费纠纷。自觉接受市场监管部门监督检查与社会公众监督，主动配合风险排查与问题整改。与此同时，为帮助广大消费者有效规避化妆品消费风险，科学安心用妆，阳泉市局同步发布化妆品安全科普知识，送上五大消费提醒。选购渠道要“正规”，源头把控安全关。线下优先选择证照齐全、信誉良好的商场超市、品牌专柜、正规美妆门店等固定场所；线上优先选择品牌官方旗舰店或已备案正规电商平台，核实商家经营资质，拒绝个人社交账号、不明链接等非正规渠道的产品。避开价格异常低廉的“三无产品”，不购买来源不明、包装破损化妆品，从源头降低消费风险。产品信息要“细看”，合规标识不能少。购买时务必核对产品“身份证”：重点查看备案/注册证号、全成分表、生产许可证编号、限用日期等关键信息，进口产品须有规范、完整中文标签。特殊化妆品（如染发、烫发、祛斑美白、防晒类）必须标注注册证编号，可通过国家药监局官网或“化妆品监管”APP查询核实。功效宣传不“盲目”，拒绝夸大噱头。警惕“7天美白”“一夜祛痘”“快速祛斑”等违背皮肤代谢规律的虚假宣传，警惕宣称医疗作用的化妆品，若产品标注“治疗炎症”“根治色斑”等医疗化用语，或炒作“量子护肤”“基因修复”等伪科技概念，需果断避开。查看成分表时，有效成分排序越靠前浓度越高，避免被“微量添加却夸大宣传”的产品误导。特殊人群要“谨慎”，科学用妆护安全。儿童皮肤敏感、耐受能力弱，原则上不使用染发、烫发类化妆品，这类产品属于高风险特殊化妆品，易引发不良反应。敏感肌人群应优先选择无酒精、无香料的温和配方产品，新购化妆品后，可先在耳后或手臂内侧小面积试用，观察48小时无红肿、瘙痒等不适后再使用。提醒哮喘患者、湿疹患者、备孕人群、孕妇或哺乳期女性以及家中有婴儿的人群应尽可能避免接触香水和其他香味产品，减少芳香物质可能对呼吸系统或皮肤带来的刺激。消费维权要“留证”，权益受损有保障。购买时要妥善留存订单截图、支付记录、购物发票、宣传页面等凭证，收到产品后核对实物与宣传是否一致，检查包装标识是否完整。若发现产品存在质量问题、虚假宣传或商家违法违规经营，可及时拨打12315热线或向当地市场监管部门投诉举报，涉及健康损害的需及时就医并保留诊断证明。

行政相对人名称鹤岗市同善堂医药经销有限公司行政相对人代码(统一社会信用代码)91230400MA1CAQHH2D法定代表人王冬梅行政处罚决定书文号鹤工农市监处罚〔2026〕12号违法行为类型当事人经营说明书不符合规定的医疗器械（脱脂棉）的行为，违反了《医疗器械说明书和标签管理规定》第十条第十三项之规定违法事实当事人于2025年6月30日从哈尔滨市康鸿医疗器械有限公司处购进第一类医疗器械“脱脂棉”（生产日期为20250105，有限期为20280104，批准文号：黑哈械备20210002号，规格50克*10小包）1包，该批次脱脂棉没有标注说明书的编制或者修订日期，1包进货金额17.00元。2025年7月5日，销售给消费者赫某1小包脱脂棉，销售价格2.50元，销售金额2.50元；剩余9小包脱脂棉已被当事人自行销毁。当事人销售没有标注说明书的编制或者修订日期脱脂棉的销售金额2.50元，违法所得2.50元；合计货值金额25.00元。处罚依据依据《医疗器械监督管理条例》第八十八条第二项、《中华人民共和国行政处罚法》第二十八条第二款之规定，处罚类别没收违法所得;罚款;其他-责令改正处罚内容责令当事人改正违法行为，并决定处罚如下： 1.没收违法所得二点五元（2.50元）； 2.罚款五百元（500.00元）；罚没款合计五百零二点五元（502.50元）。罚款金额（万元）0.05没收违法所得没收非法财物的金额（万元）0.00025处罚决定日期2026-02-10处罚有效期2099-12-31公示截止期2029-02-10处罚机关鹤岗市市场监督管理局工农分局

为规范助听器经营秩序，提升医疗器械服务质量，切实保障听力障碍群体的合法权益，青田县局“三举措”推进助听器安全防线，促进行业健康发展。 一是指导企业自查，夯实主体责任。执法人员深入各经营企业，现场指导其完成年度自查报告工作。通过详细讲解自查报告的填报事项、报送时限及具体操作流程，帮助企业明确自身责任与义务。目前，6家助听器经营企业均已按要求完成自查报告的提交，为后续监管奠定了基础。 二是紧盯关键环节，严查违法违规行为。重点核查企业是否存在超范围经营医疗器械；助听器标签标识是否规范、产品注册证是否合法有效；索证索票制度是否落实、购货渠道是否合法正规；是否及时跟踪用械信息，为消费者提供合理的用械指导等售后服务。针对检查中发现的部分企业存在索证索票不齐全、售后回访不及时等问题，执法人员当场提出整改要求，确保问题得到及时解决。 三是强化新规宣贯，提升合规经营水平。结合省局于2026年1月5日印发的《浙江省医疗器械经营质量管理规范合规指引(通则)》这一最新政策文件，执法人员向各经营企业进行了专题宣贯。督促经营者主动学习新规内容，深刻理解其核心要求，进一步落实企业主体责任，健全和完善经营质量管理体系，不断提升合规经营意识和专业管理水平，推动行业整体素质迈上新台阶。

行政相对人名称兰西县佳毅大药房有限公司行政相对人代码(统一社会信用代码)91231222MADQKU2H7A法定代表人谢宽行政处罚决定书文号兰市监处罚〔2026〕18号违法行为类型未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的行为违法事实经查，兰西县佳毅大药房有限公司于2024年7月10日办理营业执照，于2024年8月在京东购物平台提交申请注册商铺，注册商铺名称：谷财大药房旗舰店，2024年8月京东购物平台完成审核进行销售药品，当事人《药品经营许可证》于2025年7月1日办理注销，《营业执照》于2025年7月28日办理注销。经营场所已经退租不再使用。因当事人涉嫌未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品一事，本局于2026年1月9日撤销原兰西县佳毅大药房有限公司注销登记。 当事人在网络购物平台销售的规格型号为：“上海迪赛诺生物医药有限公司”生产的多格列艾汀片75mg*28片/盒；“山东步长制药股份有限公司”生产的稳心颗粒5g/袋*18袋/盒、脑心通胶囊0.4g*72粒/盒等药品，不能够提供这些药品供货方名称、地址、联系方式、相关购进票据（发票、随货同行单等）以及药品批准证明文件（药品注册证书/备案凭证）复印件。根据当事人陈述该批违法药品是在“药师帮”平台内名为晋中市新都药业有限公司购进，在经营期间未建立销售记录或账册，无法提供合法渠道购进药品的购进记录或账册，截至2025年6月当事人已经停止经营，并且在京东购物平台将违法药品全部销售完毕，没有剩余库存。经当事人确认和执法人员认定购进数量就是销售数量。 当事人在经营期间购进了规格型号为:“上海迪赛诺生物医药有限公司”生产的多格列艾汀片75mg*28片/盒购进43盒，购进价格为100元/盒；“山东步长制药股份有限公司”生产的稳心颗粒5g/袋*18袋/盒购进44盒，购进价格为35元/盒、脑心通胶囊0.4g*72粒/盒购进43盒，购进价格为31元/盒。 执法人员通过当事人手机提取的京东购物平台销售数据，当事人在京东购物平台销售规格型号为:“上海迪赛诺生物医药有限公司”生产的多格列艾汀片75mg*28片/盒销售43盒，18单，销售金额为5380.7元；“山东步长制药股份有限公司”生产的稳心颗粒5g/袋*18袋/盒销售44盒，12单，销售金额为2589.4元、脑心通胶囊0.4g*72粒/盒销售43盒，9单，销售金额为1287.2元。销售药品的快递费用由当事人承担。上述药品销售总金额为9257.3元，经执法人员确认该批违法药品货值金额为9257.3元。处罚依据《中华人民共和国药品管理法（2019修订）》 / 第一百二十九条违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按五万元计算。处罚类别罚款;没收违法所得处罚内容1.罚款人民币捌万伍仟叁佰元整（85300.00元）； 2.没收违法所得玖仟贰佰伍拾柒元叁角（9257.30元）。罚款金额（万元）8.53没收违法所得没收非法财物的金额（万元）0.92573处罚决定日期2026-02-10处罚有效期2099-12-31公示截止期2026-05-10处罚机关兰西县市场监督管理局

行政相对人名称哈尔滨英华医院有限公司行政相对人代码(统一社会信用代码)91230113MA18W31567法定代表人毕新华行政处罚决定书文号哈医保罚决字〔2026〕第48号违法行为类型一般违法问题违法事实违反《医疗保障基金使用监督管理条例》处罚依据《医疗保障基金使用监督管理条例》、《黑龙江省行使医疗保障基金使用监督管理行政处罚裁量权规定（试行）》处罚类别罚款处罚内容给予违法行为造成医保基金损失金额1倍罚款罚款金额（万元）39.5677处罚决定日期2026-02-10处罚有效期2026-02-10公示截止期2029-02-10处罚机关哈尔滨市医疗保障局