FDA Inspection
Wintec Pharmaceutical IncWintec Pharmaceutical Inc – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns Wintec Pharmaceutical Inc, with an inspection on November 19, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Wintec Pharmaceutical Inc
- Inspection Date
- November 19, 2009
- Product Type
- Veterinary
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ID · 484b6ae4-848a-4edc-a5f0-a32d5c55e99f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632306
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Wintec Pharmaceutical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 19, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Wintec Pharmaceutical Inc
- FDA Inspection 872696 - 2014-03-25
- FDA Inspection 800176 - 2012-09-19
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