FDA Inspection
TriRx Speke LimitedTriRx Speke Limited – FDA Inspection, May 9, 2013
Record Details
This FDA Inspection record concerns TriRx Speke Limited, with an inspection on May 9, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- TriRx Speke Limited
- Inspection Date
- May 9, 2013
- Product Type
- Veterinary
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ID · ce147dbd-a5b3-42ec-954a-a1544bfcb794
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831973
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
4- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of TriRx Speke Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2017 | Not classified | Office of Inspections and Investigations | |
| June 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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