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FDA Inspection
•Mericon Industries Inc.•May 27, 2011

Mericon Industries Inc. – FDA Inspection, May 27, 2011

Record Details

This FDA Inspection record concerns Mericon Industries Inc., with an inspection on May 27, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mericon Industries Inc.
Inspection Date
May 27, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 86a582fc-9940-44d1-bc42-c8c7fb19b8b7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
727375
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

8
  1. 21 CFR 211.188(b)(5)In-process and laboratory control results
  2. 21 CFR 211.160(b)Scientifically sound laboratory controls
  3. 21 CFR 211.160(a)Lab controls established, including changes
  4. 21 CFR 211.22(d)Procedures not in writing, fully followed
  5. 21 CFR 211.166(a)(3)Valid stability test methods
  6. 21 CFR 211.80(a)Procedures To Be in Writing
  7. 21 CFR 211.180(e)(2)Items to cover on annual reviews
  8. 21 CFR 211.80(a)Written Procedures Not Followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mericon Industries Inc.

5
DateClassificationOfficeProject area
February 14, 2025OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 21, 2024OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 27, 2019VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 27, 2012NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
March 11, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mericon Industries Inc.
  • FDA Inspection 1261237 - 2025-02-14
  • FDA Inspection 1247200 - 2024-08-21
  • FDA Inspection 1105178 - 2019-09-27
  • FDA Inspection 778091 - 2012-04-27
  • FDA Inspection 651780 - 2010-03-11

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