FDA Inspection
Cosway Company, Inc.Cosway Company, Inc. – FDA Inspection, Mar 10, 2017
Record Details
This FDA Inspection record concerns Cosway Company, Inc., with an inspection on March 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 33c66e01-ba9d-4b91-9a0a-43487af20bfa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006683
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(a)Approval and review of procedures
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Other FDA inspections of Cosway Company, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| October 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 840678 - 2013-07-11
- FDA Inspection 754860 - 2011-11-10
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