FDA Inspection
TOLMAR, Inc.TOLMAR, Inc. – FDA Inspection, Jul 26, 2017
Record Details
This FDA Inspection record concerns TOLMAR, Inc., with an inspection on July 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 81e2847a-9014-4e70-a7c3-c2568e74fa9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019432
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of TOLMAR, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2018 | Not classified | Denver District Office | |
| November 8, 2017 | Not classified | Denver District Office |
Other documents for TOLMAR, Inc.
- FDA Inspection 1199359 - 2023-01-31
- FDA Inspection 1118668 - 2020-02-24
- FDA Inspection 1058208 - 2018-05-30
- FDA Inspection 1038142 - 2017-11-08
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