FDA Inspection
Rebgro CorporationRebgro Corporation – FDA Inspection, Jun 27, 2012
Record Details
This FDA Inspection record concerns Rebgro Corporation, with an inspection on June 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Rebgro Corporation
- Inspection Date
- June 27, 2012
- Product Type
- Drugs
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ID · d9cc63d9-365f-4f29-b9eb-ad8a5c3e9117
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789299
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Rebgro Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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