FDA Inspection
California Center for Reproductive HealthCalifornia Center for Reproductive Health – FDA Inspection, Aug 9, 2023
Record Details
This FDA Inspection record concerns California Center for Reproductive Health, with an inspection on August 9, 2023, issued by the Los Angeles District Office.
- Inspection Date
- August 9, 2023
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ID · f2904d12-3743-44ce-b072-ac3bbf69bb84
Inspection Facts
- Inspection number
- 1214495
- FDA center
- Biologics
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
- 21 CFR 1271.55(d)(4)Ten year retention
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
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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 |
| July 12, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 1058641 - 2018-07-12
- FDA Inspection 972639 - 2016-06-07
- FDA Inspection 769379 - 2012-02-17
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