FDA Inspection
Distribuidora Comercial Jafra S.A. de C.V.Distribuidora Comercial Jafra S.A. de C.V. – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Distribuidora Comercial Jafra S.A. de C.V., with an inspection on November 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 553be9fe-ccda-4d3c-82e2-fb215a33a136
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222907
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Distribuidora Comercial Jafra S.A. de C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Distribuidora Comercial Jafra S.A. de C.V.
- FDA Inspection 1025292 - 2017-09-15
- FDA Inspection 898915 - 2014-09-29
- FDA Inspection 766693 - 2012-01-20
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