FDA Inspection
Bioinitiatives IncBioinitiatives Inc – FDA Inspection, Dec 14, 2009
Record Details
This FDA Inspection record concerns Bioinitiatives Inc, with an inspection on December 14, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bioinitiatives Inc
- Inspection Date
- December 14, 2009
- Product Type
- Biologics
View Company Profile
ID · 84a8039b-7bf1-4ba7-bff3-54578779b32f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635781
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.320(c)Review and evaluation, report to FDA
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 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 1271.270(a)Records incomplete
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Bioinitiatives Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Bioinitiatives Inc
- FDA Inspection 756768 - 2011-12-09
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