FDA Inspection
Tolmar, Inc.Tolmar, Inc. – FDA Inspection, Dec 6, 2017
Record Details
This FDA Inspection record concerns Tolmar, Inc., with an inspection on December 6, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · efa50092-0d06-4315-8a5b-c7d090d84331
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034036
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Tolmar, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2024 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| 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 |
| September 20, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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