# FDA WARNING_LETTER - Olympia Womens Health - March 01, 2013

Source: https://www.keypedia.com/records/warning_letter/olympia-womens-health/f0ea7472-abe5-454a-98c0-1e0f8ae67687

> FDA WARNING_LETTER for Olympia Womens Health on March 01, 2013. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Olympia Womens Health
- Inspection Date: 2013-03-01
- Product Type: Biologics
- Office Name: Seattle District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/charles-m-breen/ea1c624f-6943-4e12-b826-4cffbf358220)

Company: https://www.keypedia.com/companies/olympia-womens-health/fbc72810-8da9-41e1-857e-5e5067ea5279

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913