FDA Inspection
Genlabs CorporationGenlabs Corporation – FDA Inspection, Dec 11, 2015
Record Details
This FDA Inspection record concerns Genlabs Corporation, with an inspection on December 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genlabs Corporation
- Inspection Date
- December 11, 2015
- Product Type
- Drugs
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ID · d3184bbe-dbbd-4ca7-b1e6-cb73456878be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953128
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Genlabs Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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