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FDA Inspection
•Advanced Generic Corporation•August 1, 2011

Advanced Generic Corporation – FDA Inspection, Aug 1, 2011

Record Details

This FDA Inspection record concerns Advanced Generic Corporation, with an inspection on August 1, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Advanced Generic Corporation
Inspection Date
August 1, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4ab6235c-b3d9-46f7-b658-6f50c9665eb2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
738728
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

6
  1. 21 CFR 211.198(a)Adverse Drug Experience
  2. 21 CFR 211.25(b)Supervisor Training/Education/Experience
  3. 21 CFR 111.12Personnel - quality control personnel - qualified
  4. 21 CFR 211.22(d)Procedures not in writing, fully followed
  5. 21 CFR 111.103Written procedures - quality control operations
  6. 21 CFR 111.103Written procedure quality control operations material review

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Advanced Generic Corporation

4
DateClassificationOfficeProject area
March 23, 2026NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
July 23, 2018NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
May 7, 2015NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
February 27, 2012NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Advanced Generic Corporation
  • FDA Inspection 1309366 - 2026-03-23
  • FDA Inspection 1067077 - 2018-07-23
  • FDA Inspection 925397 - 2015-05-07
  • FDA Inspection 769040 - 2012-02-27

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