FDA Inspection
Pacific Coast Reproductive Center IncFDA Inspection 1263646 - Pacific Coast Reproductive Center Inc - March 12, 2025
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Record Details
This FDA Inspection record concerns Pacific Coast Reproductive Center Inc, with an inspection on March 12, 2025, issued by the Los Angeles District Office, covering biologics.
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ID · a1b03382-b838-4686-b2e3-a0f8651d1b32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263646
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.55(b)(3)Name and address on summary
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Pacific Coast Reproductive Center Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 24, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |