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FDA Inspection
•Contract Pharmacal Corporation•May 20, 2011

Contract Pharmacal Corporation – FDA Inspection, May 20, 2011

Record Details

This FDA Inspection record concerns Contract Pharmacal Corporation, with an inspection on May 20, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Contract Pharmacal Corporation
Inspection Date
May 20, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · b8b638ec-690e-42b2-a3b0-530b4cdbd9ee

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
725920
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  2. 21 CFR 211.160(b)Scientifically sound laboratory controls
  3. 21 CFR 211.198(a)Complaint Handling Procedure
  4. 21 CFR 211.204Returned drug procedures in writing and followed
  5. 21 CFR 211.22(d)Procedures not in writing, fully followed
  6. 21 CFR 211.166(a)(3)Valid stability test methods
  7. 21 CFR 211.198(a)Reporting of adverse drug experience to FDA

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Contract Pharmacal Corporation

15
DateClassificationOfficeProject area
August 24, 2026NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 14, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 22, 2017NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 15, 2017NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
December 9, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 15 other inspections on the company page
Other documents for Contract Pharmacal Corporation
  • FDA Inspection 1325620 - 2026-08-24
  • FDA Inspection 1167279 - 2022-04-14
  • FDA Inspection 1036595 - 2017-11-22
  • FDA Inspection 1026688 - 2017-08-15
  • FDA Inspection 994796 - 2016-12-09

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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
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