FDA Inspection
Custom HBC CorporationCustom HBC Corporation – FDA Inspection, Mar 28, 2011
Record Details
This FDA Inspection record concerns Custom HBC Corporation, with an inspection on March 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Custom HBC Corporation
- Inspection Date
- March 28, 2011
- Product Type
- Drugs
View Company Profile
ID · 92152397-a09d-4964-a5ec-089a13c8af4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716802
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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