FDA Inspection
Les Entreprises Stefmar Inc.Les Entreprises Stefmar Inc. – FDA Inspection, Jan 18, 2018
Record Details
This FDA Inspection record concerns Les Entreprises Stefmar Inc., with an inspection on January 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b3f18616-9f1b-4d85-8875-61744e0c8d7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040770
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures fail to include
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