FDA Inspection
Tropichem Research Labs, LLC dba VetioTropichem Research Labs, LLC dba Vetio – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Tropichem Research Labs, LLC dba Vetio, with an inspection on December 14, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 78275490-e7da-4d02-9318-29fd7705af8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074424
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Tropichem Research Labs, LLC dba Vetio
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2025 | Not classified | Florida District Office | Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| February 14, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 22, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 21, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 23, 2013 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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