FDA Inspection
Brioschi Pharmaceuticals International LLCBrioschi Pharmaceuticals International LLC – FDA Inspection, Apr 25, 2012
Record Details
This FDA Inspection record concerns Brioschi Pharmaceuticals International LLC, with an inspection on April 25, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 25, 2012
- Product Type
- Drugs
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ID · d26c0df5-1aaf-4c09-8a52-8166f243bc71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778051
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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