FDA Inspection
Olympia Women's HealthOlympia Women's Health – FDA Inspection, Dec 16, 2014
Record Details
This FDA Inspection record concerns Olympia Women's Health, with an inspection on December 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Olympia Women's Health
- Inspection Date
- December 16, 2014
- Product Type
- Biologics
View Company Profile
ID · d9b6ad00-8946-4c4a-a684-3e21b58bb14e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 907429
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Olympia Women's Health
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | Seattle District Office | Human Cellular, Tissue, and Gene Therapies |
| October 20, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 13, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 22, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 29, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Olympia Women's Health
- FDA Inspection 1325052 - 2026-06-30
- FDA Inspection 1190768 - 2022-10-20
- FDA Inspection 1027846 - 2017-09-13
- FDA Inspection 979044 - 2016-07-22
- FDA Inspection 854710 - 2013-10-29
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