FDA Inspection
Thomas Labs, LLCThomas Labs, LLC – FDA Inspection, Jul 17, 2019
Record Details
This FDA Inspection record concerns Thomas Labs, LLC, with an inspection on July 17, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · d0e3c652-4816-447f-abca-1bf1294b0dc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096541
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.180(e)(2)Review of problem drugs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Thomas Labs, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 7, 2017 | Not classified | Denver District Office | |
| December 21, 2016 | VAI | Denver District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 1067356 - 2018-09-26
- FDA Inspection 1020087 - 2017-06-07
- FDA Inspection 1017179 - 2016-12-21
- FDA Inspection 884848 - 2014-06-25
- FDA Inspection 612418 - 2009-09-14
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