FDA Inspection
Nowcos Co., LtdNowcos Co., Ltd – FDA Inspection, Aug 4, 2017
Record Details
This FDA Inspection record concerns Nowcos Co., Ltd, with an inspection on August 4, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e2e1a08e-edcc-448e-8f19-78fdd0938605
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1020295
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Nowcos Co., Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| September 6, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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