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WARNING LETTER

Emmett F. Branigan, MD, PS, Inc MARCS-CMS 548705 —


Delivery Method:
UPS

Recipient:
Recipient Name
Emmett F. Branigan, MD, PS
Emmett F. Branigan, MD, PS, Inc

2980 Squalicum Parkway, Suite 103

Bellingham, WA 98225-1880
United States

Issuing Office:
Los Angeles District Office

United States


 

  

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WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
May 07, 2018 
                                                                                               Warning Letter #OBPO 18-03
Emmett F. Branigan, MD
Owner / Medical Director
2980 Squalicum Parkway, Suite 103
Bellingham, WA 98225-1880
 
Dear Dr. Branigan,
 
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Emmett F. Branigan, MD, PS, Inc., located at 2980 Squalicum Parkway, Suite 103, Bellingham, WA 98225, from January 29 through January 31, 2018. During the inspection, an FDA Investigator documented significant deviations from the regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, 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 deviations documented on the Form FDA-483, List of Inspectional Observations, were presented to and discussed with you at the conclusion of the inspection. These deviations are discussed below. The items of concern include, but are not limited to the following:
 
1.      Failure to test a specimen from the donor of cells or tissue for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example, anonymous oocyte donor (b)(6) was determined to be eligible on (b)(4) 2017, without Chlamydia trachomatisNeisseria gonorrhea, HIV-1/HBV/HCV and WNV nucleic acid testing (NAT).
 
2.      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)]. For example,  
 
a)      FDA has identified Zika virus (ZIKV) as a  relevant communicable disease agent or disease (RCDAD) under 21 CFR 1271.3(r)(2). Therefore, review of relevant medical records, as defined in 21 CFR 1271.3(s), must indicate that a potential donor is free from risk factors for, or clinical evidence of, ZIKV infection for the purpose of determining donor eligibility. Your “Donor Medical History Interview” form does not include questions to assess a donor’s relevant communicable disease risk as it relates to ZIKV. The following donors were not screened for ZIKV at the time of donation:  
  • Anonymous oocyte donor (b)(6) [donor questionnaire dated (b)(4), 2016]  
  • Anonymous oocyte donor (b)(6) [donor questionnaire dated (b)(4), 2016]  
  • Anonymous oocyte donor (b)(6) [donor eligibility determinations dated (b)(4), 2017 and (b)(4), 2017]
  • Anonymous oocyte donor (b)(6) [donor questionnaire dated (b)(4), 2016] 
b)      Your standard operating procedure entitled “Procedure Manual for the Assisted Reproductive Technology Laboratory” indicates a “full screening includes a donor medical history interview, physical examination, and medical records review.” The “Donor Physical Assessment Form”, “Donor Physical Assessment Form (A)” and “Donor Medical History Interview” are relevant medical records used by your firm to determine donor eligibility. Your firm failed to complete these relevant medical records before finding anonymous oocyte donor (b)(6) to be eligible on (b)(4), 2017 and (b)(4), 2017. 
  
3.      Failure of a responsible person to determine and document the eligibility of a cell or tissue donor as required by 21 CFR 1271.50(a). A responsible person, as defined in 21 CFR 1271.3(t), must determine and document the eligibility of a cell or tissue donor. For example, a responsible person failed to sign the “DonorEligibility Determination Form” for anonymous oocyte donor (b)(6). Anonymous oocyte donor (b)(6) was determined to be eligible on (b)(4), 2016.
 
4.      Failure to establish and maintain procedures for all steps performed in testing,  screening, and determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part1271.45-1271.90. “Establish and maintain” means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. As a result, your donors may not have been screened in accordance with 21 CFR 1271.75.  For example, your firm failed to establish and/or update your standard operating procedure(s) and relevant medical records in order to evaluate donor eligibility.  
 
a)       The “Donor Medical History Interview Form” does not include complete and/or accurate questions related to the following conditions and behaviors that increase the donor’s relevant communicable disease risk. 
  • Question #26 on your “Donor Medical History Interview Form” omitted France.
  • Question #24 on your “Donor Medical History Interview Form” lacks the qualifier “cumulative” preceding the 6 month criteria for residing at a U.S. military base in Northern Europe from 1980-1990 or residing elsewhere in Europe from 1980-1996. Furthermore, the question does not identify the specific countries related to this screening question
  • Question #8 on your “Donor Medical History Interview Form” does not include the various types of Hepatitis.  .
b)      Our review of your “Procedure Manual for the Assisted Reproductive Technology Laboratory” identified the following:
  • The procedure does not include WNV-NAT testing as required for HCT/P donors. WNV-NAT testing is not listed under your “list of tests conducted for donors” and a part of the “summary of test results” to determine donor eligibility.
  • Your procedure states “A positive test to HBsAg may not make the donor ineligible”. As required under 21 CFR 1271.80(d)(1), you must determine to be ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent, including Hepatitis B virus. Accordingly, you are required to determine as ineligible a donor who tests reactive for HBsAg 
To date, we have not received a response to the observations on the FDA-483 provided to you at the close of the inspection; therefore, we are unable to evaluate what, if any, corrective actions you have implemented, or plan to implement and whether they are adequate to address our concerns.
 
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all applicable requirements of the federal regulations. You are responsible for reviewing your firm’s operations as a whole to assure that you are in compliance with all of the FDA regulatory requirements.
 
You should take prompt action to correct the violations addressed in this letter and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action being initiated by the 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 the noted violations and prevent their recurrence. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed.
 
Your response should be sent to the following address: Daniel W. Cline, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612 or emailed to Daniel.Cline@fda.hhs.gov. If you should have any questions, please contact Daniel Cline, Compliance Officer at 949-608-4433 or via e-mail.
 
Sincerely,
/S/ 
Karlton Watson
Program Division Director
Office of Biological Products Operations - Division 2
 

 

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