FDA Inspection
Laboratoire AguettantLaboratoire Aguettant – FDA Inspection, Nov 6, 2018
Record Details
This FDA Inspection record concerns Laboratoire Aguettant, with an inspection on November 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 076e1343-8536-4067-bffc-3f29bae8a6ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070996
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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