FDA Inspection
Tolmar, Inc.Tolmar, Inc. – FDA Inspection, Sep 7, 2012
Record Details
This FDA Inspection record concerns Tolmar, Inc., with an inspection on September 7, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tolmar, Inc.
- Inspection Date
- September 7, 2012
- Product Type
- Drugs
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ID · df72f23e-64bf-4c7a-8f3c-9c7e12587dcb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797945
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192No written record of investigation
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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 |
| December 6, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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