FDA Inspection
California Center for Reproductive HealthCalifornia Center for Reproductive Health – FDA Inspection, Jul 12, 2018
Record Details
This FDA Inspection record concerns California Center for Reproductive Health, with an inspection on July 12, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6549e807-3b60-416a-834f-4b3bb2d52dcb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058641
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
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Other FDA inspections of California Center for Reproductive Health
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 9, 2023 | Not classified | Los Angeles District Office | |
| June 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 17, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for California Center for Reproductive Health
- FDA Inspection 1243852 - 2024-07-15
- FDA Inspection 1214495 - 2023-08-09
- FDA Inspection 972639 - 2016-06-07
- FDA Inspection 769379 - 2012-02-17
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