FDA Inspection
Cohance Lifesciences LimitedCohance Lifesciences Limited – FDA Inspection, Feb 6, 2018
Record Details
This FDA Inspection record concerns Cohance Lifesciences Limited, with an inspection on February 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9518de2d-f33b-4391-82d2-a86651e32345
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040233
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Cohance Lifesciences Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2025 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| August 20, 2019 | 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 1278348 - 2025-08-12
- FDA Inspection 1100953 - 2019-08-20
- FDA Inspection 980924 - 2016-07-12
- FDA Inspection 853289 - 2013-10-11
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