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WARNING LETTER

Westlake IVF, LLC MARCS-CMS 590113 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
OBPO 19-10
Product:
Biologics

Recipient:
Recipient Name
Shahryar K. Kavoussi, MD, MPH, FACOG
Westlake IVF, LLC

300 Beardsley Lane Building B Suite 200
Austin, TX 78746-4945
United States

Issuing Office:
Office of Biological Products Operations - Division 2

550 W. Jackson
Chicago, IL 60661
United States


WARNING LETTER

September 30, 2019

#OBPO 19-10


Dear Dr. Kavoussi,

The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Westlake IVF, LLC, located at 300 Beardsley Lane Building B Suite 200 Austin, TX, from May 20 through May 31, 2019. During the inspection, the FDA Investigator documented significant deviations from the regulations for 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 a Form FDA 483, List of lnspectional Observations, were presented to and discussed with you at the conclusion of the inspection. Additional deviations were noted upon further review of the donor records and procedures collected during the inspection. These deviations are discussed below. The items of concern include, but are not limited to the following:

1. Failure of a responsible person to determine and document the eligibility of a cell or tissue donor based upon the results of donor screening and donor testing [21 CFR 1271.50(a)]. For example:

a. There was no donor eligibility determination for directed oocyte donor (b)(6) 
b. There was no donor eligibility determination for directed semen donor (b)(6).

2. 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)]. Five anonymous oocyte donors had no records indicating West Nile Virus (WNV) Nucleic Acid Testing (NAT) was performed on their samples collected June 1st through October 31st. For example, three of the five donors not tested for WNV are as follows:

a. Oocyte donor (b)(6) donor sample collected on (b)(6) and was not tested for WNV. This donor was determined eligible on October 03, 2016.
b. Oocyte donor (b)(6) donor sample collected on (b)(6) and was not tested forWNV. This donor was determined eligible on June 09, 2017.
c. Oocyte donor (b)(6) donor sample was collected on (b)(6) and was not tested for WNV. This donor was determined eligible on July 11, 2017.

3. 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)]. For example, FDA has identified the Zika virus (ZIKV), as a relevant communicable disease agent or disease under 21 CFR 1271.3(r)(2). Your Donor Risk Assessment questionnaire failed to assess ten anonymous oocytes donor's relevant communicable disease risk as it relates to ZIKV transmission. For example, three of the ten donors that were not screened for ZIKV infection are as follows:

a. Oocyte donor (b)(6) was determined eligible on April 21, 2016,
b. Oocyte donor (b)(6) was determined eligible on July 11, 2017.
c. Oocyte donor (b)(6) was determined eligible on June 09, 2017.

4. Failure to complete an abbreviated donor screening procedure [21 CFR 1271.75 (e)]. For example, the "Relevant Communicable Disease Questionnaire" for anonymous oocyte donor (b)(6) was completed on (b)(6). Oocytes were recovered on (b)(6) without determining and documenting any changes in the donor's medical history since the previous donation that would make the donor ineligible, including relevant social behavior.

5. 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 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:

a. Your procedure entitled "Procedure Manual for the Assisted Reproductive Technology Facilities", does not state that donors should be tested for WNV between June 1st and October 31st and screened for the ZIKV. Your procedure was last reviewed on June 05, 2017.
b. Your SOP entitled, "" does not include HIV1/HCV/HBV Nucleic Acid Testing (NAT) and your "Donor Eligibility Determination and Summary of Records" form does not include HBV NAT.

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.

Additional information regarding regulatory requirements for HCT/P's can be located on the FDA website:
https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidances
https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products

We acknowledge receipt of your written response, dated June 10, 2019, which provides a response and corrective actions to FDA's inspectional observations (FDA-483). We note that you have committed to implementing new procedures and re-training your staff. The effectiveness of your corrective actions will be evaluated during the next inspection.

In response to Observation 4, you stated that you are updating your procedure manual titled "Procedure Manual for the Assisted Reproductive Technology Facilities" v 2.00 to state that donors should be tested for WNV between June 1st and October 1st [sic] and screened for the ZIKV. Please note the correct date of the testing period for WNV is June 1st through October 31st.

If you still have oocytes in storage from donors who were not tested for WNV and/or screened for risk factors for relevant communicable diseases or disease agents in accordance with the regulations in 21 CFR Part 1271, 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 oocytes or semen from quarantine, either for use in your own establishment or for transport to another establishment, you must 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: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/ExemptionsandAlternativeProcedures/default.htm). Please note that the 21 CFR 1271.155 regulation 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 part 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 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: Sam Labinjo, U.S. Food and Drug Administration, 550 W. Jackson, Ste. 1500 Chicago IL 60661 or emailed to Samuel.labinjo@fda.hhs.gov. If you should have any questions, please contact Sam Labinjo, Compliance Officer at 312-596-4254 or via e-mail.

Sincerely,

/S/

Karlton Watson
Program Division Director
Office of Biological Products Operations - Division 2