FDA Inspection
IKI Mfg Co., IncIKI Mfg Co., Inc – FDA Inspection, Apr 13, 2010
Record Details
This FDA Inspection record concerns IKI Mfg Co., Inc, with an inspection on April 13, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- IKI Mfg Co., Inc
- Inspection Date
- April 13, 2010
- Product Type
- Drugs
View Company Profile
ID · 768169ec-0d1c-4481-8d60-2ca367f566db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657369
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.100(a)Approval and review of procedures
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Other FDA inspections of IKI Mfg Co., Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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