FDA Inspection
CBICBI – FDA Inspection, Apr 30, 2009
Record Details
This FDA Inspection record concerns CBI, with an inspection on April 30, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CBI
- Inspection Date
- April 30, 2009
- Product Type
- Drugs
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ID · f4f9a382-47db-4ee3-9b52-3af171c2a200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 582550
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.165(d)Acceptance/Rejection Levels
- 21 CFR 211.67(b)Written procedures fail to include
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