FDA Inspection
Thomas Labs, LLCThomas Labs, LLC – FDA Inspection, Dec 21, 2016
Record Details
This FDA Inspection record concerns Thomas Labs, LLC, with an inspection on December 21, 2016, issued by the Denver District Office, covering animal drugs & feeds.
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ID · 03f6f86e-baba-4b30-a782-94c991338246
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017179
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Thomas Labs, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 26, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 7, 2017 | Not classified | Denver District Office | |
| June 25, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 14, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Thomas Labs, LLC
- FDA Inspection 1096541 - 2019-07-17
- FDA Inspection 1067356 - 2018-09-26
- FDA Inspection 1020087 - 2017-06-07
- FDA Inspection 884848 - 2014-06-25
- FDA Inspection 612418 - 2009-09-14
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