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FDA Inspection
•Arzol Chemical Company•December 19, 2011

FDA Inspection 759807 - Arzol Chemical Company - December 19, 2011

Record Details

This FDA Inspection record concerns Arzol Chemical Company, with an inspection on December 19, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Arzol Chemical Company
Inspection Date
December 19, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 17537529-f701-4455-aa92-1307aef68aea

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
759807
FDA center
Human Drugs
Project area
Unapproved and Misbranded Drugs

FDA Citations

4
  1. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  2. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  3. 21 CFR 211.100(a)Absence of Written Procedures
  4. 21 CFR 211.166(a)Written program not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Arzol Chemical Company

4
DateClassificationOfficeProject area
June 14, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 25, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 23, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 14, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Arzol Chemical Company
  • FDA Inspection 1241346 - 2024-06-14
  • FDA Inspection 958730 - 2016-01-25
  • FDA Inspection 869538 - 2014-01-23
  • FDA Inspection 599328 - 2009-07-14

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