FDA Inspection
IKI Mfg Co., IncIKI Mfg Co., Inc – FDA Inspection, May 6, 2009
Record Details
This FDA Inspection record concerns IKI Mfg Co., Inc, with an inspection on May 6, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- IKI Mfg Co., Inc
- Inspection Date
- May 6, 2009
- Product Type
- Drugs
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ID · 26a4884d-0de2-42c7-a238-e79d10c390ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 580045
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| April 13, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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