FDA Inspection
Depuy San AntonioDepuy San Antonio – FDA Inspection, Oct 28, 2009
Record Details
This FDA Inspection record concerns Depuy San Antonio, with an inspection on October 28, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Depuy San Antonio
- Inspection Date
- October 28, 2009
- Product Type
- Biologics
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ID · 76cf81d4-7146-4116-afe5-dd0e27ad1d5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 625478
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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