FDA Inspection
Tolmar, Inc.Tolmar, Inc. – FDA Inspection, Feb 23, 2024
Record Details
This FDA Inspection record concerns Tolmar, Inc., with an inspection on February 23, 2024, issued by the Center for Drug Evaluation and Research.
- Company
- Tolmar, Inc.
- Inspection Date
- February 23, 2024
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ID · fb1f2ab6-a071-4648-bfcf-cc62cc482c62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230026
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Tolmar, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 6, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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