FDA Inspection
Olympia Women's HealthOlympia Women's Health – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Olympia Women's Health, with an inspection on March 1, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Olympia Women's Health
- Inspection Date
- March 1, 2013
- Product Type
- Biologics
View Company Profile
ID · 24d88ec9-e37c-49aa-a2e6-0dc9c1ce8f30
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 820698
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
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 |
| December 16, 2014 | 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 907429 - 2014-12-16
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