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FDA Inspection
•PharmPak, Inc.•May 23, 2012

PharmPak, Inc. – FDA Inspection, May 23, 2012

Record Details

This FDA Inspection record concerns PharmPak, Inc., with an inspection on May 23, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
PharmPak, Inc.
Inspection Date
May 23, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 3c5b07cb-348e-45f8-bdc8-87aa1733f86c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
782439
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.44Adequate lighting not provided
  2. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  3. 21 CFR 211.68(a)Calibration/Inspection/Checking not done

Full citation text and observation details available on the Dashboard.

Other FDA inspections of PharmPak, Inc.

3
DateClassificationOfficeProject area
December 9, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 17, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 18, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for PharmPak, Inc.
  • FDA Inspection 1158404 - 2021-12-09
  • FDA Inspection 1013244 - 2017-03-17
  • FDA Inspection 667218 - 2010-06-18

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