FDA Inspection
Thorn BioScience LLCThorn BioScience LLC – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns Thorn BioScience LLC, with an inspection on May 23, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · c68c9a34-ddfb-4812-ac14-bea421609ed0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052929
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.208No records maintained
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Thorn BioScience LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2024 | OAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| January 19, 2024 | OAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| May 26, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 7, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 15, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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