FDA Inspection
Cosco Enterprises Inc.Cosco Enterprises Inc. – FDA Inspection, Mar 26, 2024
Record Details
This FDA Inspection record concerns Cosco Enterprises Inc., with an inspection on March 26, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1aacd4a9-d370-4d68-bcf0-543941312da2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235016
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Cosco Enterprises Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosco Enterprises Inc.
- FDA Inspection 989528 - 2016-10-27
- FDA Inspection 731950 - 2011-06-28
- FDA Inspection 656105 - 2010-04-06
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