FDA Inspection
Summit Aire Inc.Summit Aire Inc. – FDA Inspection, Dec 17, 2009
Record Details
This FDA Inspection record concerns Summit Aire Inc., with an inspection on December 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Summit Aire Inc.
- Inspection Date
- December 17, 2009
- Product Type
- Drugs
View Company Profile
ID · e98f1742-7710-4b66-8551-52747aa61200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635496
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 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 211.142Written warehousing procedures established/followed
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Summit Aire Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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