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FDA Inspection
•Distribuidora Comercial Jafra S.A. de C.V.•September 29, 2014

Distribuidora Comercial Jafra S.A. de C.V. – FDA Inspection, Sep 29, 2014

Record Details

This FDA Inspection record concerns Distribuidora Comercial Jafra S.A. de C.V., with an inspection on September 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Distribuidora Comercial Jafra S.A. de C.V.
Inspection Date
September 29, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · c04b096a-7a2f-4ce6-8249-715c83799203

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
898915
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

6
  1. 21 CFR 211.122(d)Label storage access limited to authorized personnel
  2. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  3. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  4. 21 CFR 211.100(a)Absence of Written Procedures
  5. 21 CFR 211.192Written record of investigation incomplete
  6. 21 CFR 211.182Written records kept in individual logs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Distribuidora Comercial Jafra S.A. de C.V.

3
DateClassificationOfficeProject area
November 17, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 15, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 20, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Distribuidora Comercial Jafra S.A. de C.V.
  • FDA Inspection 1222907 - 2023-11-17
  • FDA Inspection 1025292 - 2017-09-15
  • FDA Inspection 766693 - 2012-01-20

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