Washington Fertility Center

Warning LetterOpen

Pierre Asmar, M.D. President and Medical Director Washington Fertility Center 4316 Evergreen Lane Annandale , VA 22003-2070 United StatesFEI 3005668178Issued Apr 30, 2024Division of Biological Products Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005668178.

Violations11

Issue DateApr 30, 2024

Product TypeBiologics

StatusOpen

Letter Details

Firm: Washington Fertility Center
Location: Pierre Asmar, M.D. President and Medical Director Washington Fertility Center 4316 Evergreen Lane Annandale , VA 22003-2070 United States
FEI Number: 3005668178
Country: United States
Issue Date: April 30, 2024
Issuing Office: Division of Biological Products Operations I
Product Type: Biologics
Status: Open

Summary

Washington Fertility Center, a biologics manufacturer specializing in reproductive cells and tissues, failed to comply with federal regulations for human cells, tissues, and cellular products (HCT/Ps) under 21 CFR Part 1271. Specific violations included the failure to test donor specimens for communicable diseases such as HIV-1, HCV, and HBV using nucleic acid testing methods, and the failure to properly screen donors through current medical history interviews and physical examination reports as required by federal law. These deviations were documented during an FDA inspection conducted between October and November 2023 at the company's Annandale, Virginia facility.

Washington Fertility Center FDA Warning Letter, April 30, 2024