FDA Inspection
Kenwick IncKenwick Inc – FDA Inspection, Jul 30, 2010
Record Details
This FDA Inspection record concerns Kenwick Inc, with an inspection on July 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kenwick Inc
- Inspection Date
- July 30, 2010
- Product Type
- Drugs
View Company Profile
ID · c8614df9-09b9-49c9-8dd0-2ec6623e3db1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 673060
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.84(c)(6)Containers Marked to Show Samples Taken
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.122(a)Written procedures not followed
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Other FDA inspections of Kenwick Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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