FDA Inspection
Agbanga Karite LLCAgbanga Karite LLC – FDA Inspection, Apr 24, 2013
Record Details
This FDA Inspection record concerns Agbanga Karite LLC, with an inspection on April 24, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Agbanga Karite LLC
- Inspection Date
- April 24, 2013
- Product Type
- Drugs
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ID · 0d3962d2-82e0-408a-8fa4-50f8f39c8491
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 827033
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Agbanga Karite LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2018 | Not classified | Seattle District Office | |
| November 13, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Agbanga Karite LLC
- FDA Inspection 1048528 - 2018-03-21
- FDA Inspection 967457 - 2015-11-13
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