Olympia Womens Health – FDA Warning Letter, Mar 1, 2013

The FDA inspected Olympia Women's Health from February 25 to March 1, 2013, identifying significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations include: - Failure to determine a donor ineligible despite reactive screening tests (e.g., Chlamydia trachomatis positive oocyte donor # (b)(6) ). - Incomplete testing for relevant communicable disease agents, specifically lacking HIV-1/HCV NAT and total anti-HBc for anonymous/directed reproductive donors. - Failure to use FDA-licensed/approved/cleared donor screening tests, with no documentation from the contract laboratory. - Failure to determine donor eligibility based on complete screening and testing for three directed semen donors. - Inadequate donor screening, including lack of current physical examination reports for anonymous oocyte donor # (b)(6) . - Failure of a responsible person to document donor eligibility prior to donation for multiple oocyte donors. - Improper HCT/P identification codes, with multiple codes for a single anonymous oocyte donor. - Inadequate procedures for donor eligibility, lacking HIV-1/HCV NAT as a required screening test in SOPs. - Failure to label HCT/Ps with "NOT EVALUATED FOR INFECTIOUS SUBSTANCES" when applicable, or "WARNING: Advise recipient