FDA Inspection
Summit Aire Inc.Summit Aire Inc. – FDA Inspection, Apr 19, 2012
Record Details
This FDA Inspection record concerns Summit Aire Inc., with an inspection on April 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Summit Aire Inc.
- Inspection Date
- April 19, 2012
- Product Type
- Drugs
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ID · 5fe91db1-8f65-46b8-a12f-1b75a66cf105
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778499
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Summit Aire Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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