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FDA Inspection
•Cosway Company, Inc.•February 24, 2023

Cosway Company, Inc. – FDA Inspection, Feb 24, 2023

Record Details

This FDA Inspection record concerns Cosway Company, Inc., with an inspection on February 24, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Cosway Company, Inc.
Inspection Date
February 24, 2023
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Heidy C. Perales (Company Rep)
View Company Profile

ID · df038495-7605-4e4a-8ea3-0e160045fbb7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1198266
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.142(b)Storage under appropriate conditions
  2. 21 CFR 211.160(b)Scientifically sound laboratory controls
  3. 21 CFR 211.142(b)Storage under appropriate conditions
  4. 21 CFR 211.160(b)Scientifically sound laboratory controls

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
March 10, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 11, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 10, 2011VAICenter 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 1006683 - 2017-03-10
  • FDA Inspection 840678 - 2013-07-11
  • FDA Inspection 754860 - 2011-11-10

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