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FDA Inspection
•Cosway Company, Inc.•April 8, 2011

Cosway Company, Inc. – FDA Inspection, Apr 8, 2011

Record Details

This FDA Inspection record concerns Cosway Company, Inc., with an inspection on April 8, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Cosway Company, Inc.
Inspection Date
April 8, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · ef8687f7-1d65-4914-ad3b-1c2a5f9e512d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
720401
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

8
  1. 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
  2. 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
  3. 21 CFR 211.137(a)Expiration date lacking
  4. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  5. 21 CFR 211.165(c)Sampling and testing plans not described
  6. 21 CFR 211.180(e)(2)Review of problem drugs
  7. 21 CFR 211.192Investigations of discrepancies, failures
  8. 21 CFR 211.166(a)Written program not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cosway Company, Inc.

7
DateClassificationOfficeProject area
September 6, 2024NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
October 27, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 24, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 10, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 11, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Cosway Company, Inc.
  • FDA Inspection 1250780 - 2024-09-06
  • FDA Inspection 1224437 - 2023-10-27
  • FDA Inspection 1198266 - 2023-02-24
  • FDA Inspection 1006683 - 2017-03-10
  • FDA Inspection 840678 - 2013-07-11

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