FDA Inspection
East Bay Fertility Center Inc.East Bay Fertility Center Inc. – FDA Inspection, Dec 13, 2010
Record Details
This FDA Inspection record concerns East Bay Fertility Center Inc., with an inspection on December 13, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 13, 2010
- Product Type
- Biologics
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ID · f2c8d266-8057-4ee1-a498-5aea99d290b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 701686
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
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