FDA Inspection
Vortech Pharmaceuticals LtdVortech Pharmaceuticals Ltd – FDA Inspection, Dec 14, 2012
Record Details
This FDA Inspection record concerns Vortech Pharmaceuticals Ltd, with an inspection on December 14, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Vortech Pharmaceuticals Ltd
- Inspection Date
- December 14, 2012
- Product Type
- Veterinary
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ID · b9dfbbb7-18ca-411c-8bf5-eb80dd7af482
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810555
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Vortech Pharmaceuticals Ltd
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2024 | Not classified | Detroit District Office | |
| February 9, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 21, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 16, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 22, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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