FDA Inspection
TOLMAR 1413 ACQUISITION, LLCTOLMAR 1413 ACQUISITION, LLC – FDA Inspection, Sep 11, 2018
Record Details
This FDA Inspection record concerns TOLMAR 1413 ACQUISITION, LLC, with an inspection on September 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f1c66e17-7cd8-45c5-8b80-967ae41a7d92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065361
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of TOLMAR 1413 ACQUISITION, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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