FDA Inspection
TOLMAR 1413 ACQUISITION, LLCTOLMAR 1413 ACQUISITION, LLC – FDA Inspection, Jun 18, 2015
Record Details
This FDA Inspection record concerns TOLMAR 1413 ACQUISITION, LLC, with an inspection on June 18, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- TOLMAR 1413 ACQUISITION, LLC
- Inspection Date
- June 18, 2015
- Product Type
- Drugs
View Company Profile
ID · 92c9458c-d7e8-4899-991c-703bdca3adb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930611
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of TOLMAR 1413 ACQUISITION, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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