FDA Inspection
Cloetta ItaliaCloetta Italia – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns Cloetta Italia, with an inspection on July 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6a4c882b-b880-4d59-95c8-74928c33910d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020218
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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