FDA Inspection
TOLMAR, Inc.TOLMAR, Inc. – FDA Inspection, Feb 24, 2020
Record Details
This FDA Inspection record concerns TOLMAR, Inc., with an inspection on February 24, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- TOLMAR, Inc.
- Inspection Date
- February 24, 2020
- Product Type
- Drugs
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ID · 8d1ae298-437b-451a-9511-68fdef3bd19a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118668
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
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 |
| May 30, 2018 | Not classified | Denver District Office | |
| November 8, 2017 | Not classified | Denver District Office | |
| July 26, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for TOLMAR, Inc.
- FDA Inspection 1199359 - 2023-01-31
- FDA Inspection 1058208 - 2018-05-30
- FDA Inspection 1038142 - 2017-11-08
- FDA Inspection 1019432 - 2017-07-26
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