FDA Inspection
Cohance Lifesciences LimitedCohance Lifesciences Limited – FDA Inspection, Aug 12, 2025
Record Details
This FDA Inspection record concerns Cohance Lifesciences Limited, with an inspection on August 12, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 1d158486-2891-4552-84d7-41a7ce5097cd
Inspection Facts
- Inspection number
- 1278348
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Cohance Lifesciences Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cohance Lifesciences Limited
- FDA Inspection 1100953 - 2019-08-20
- FDA Inspection 1040233 - 2018-02-06
- FDA Inspection 980924 - 2016-07-12
- FDA Inspection 853289 - 2013-10-11
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