FDA Inspection
Cofran International CorpCofran International Corp – FDA Inspection, Jan 6, 2017
Record Details
This FDA Inspection record concerns Cofran International Corp, with an inspection on January 6, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d5857f8c-9ab5-4b3e-8fb4-960a3bef0afa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999128
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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