FDA Inspection
Guthy-Renker LLCGuthy-Renker LLC – FDA Inspection, Jan 6, 2012
Record Details
This FDA Inspection record concerns Guthy-Renker LLC, with an inspection on January 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Guthy-Renker LLC
- Inspection Date
- January 6, 2012
- Product Type
- Drugs
View Company Profile
ID · e16e2d75-5609-4fed-a683-25c8d1f7f88e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756891
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- No AE report made (dietary supplement)
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- Failure of responsible person to report AE (non-RX Drug)
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 111.553Written procedures - product complaint
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