FDA Inspection
Cohance Lifesciences LimitedCohance Lifesciences Limited – FDA Inspection, Aug 20, 2019
Record Details
This FDA Inspection record concerns Cohance Lifesciences Limited, with an inspection on August 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2ef52a98-0b44-4441-8128-065649e3ee85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100953
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(c)Approve or reject procedures or specs
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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 |
| 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 1278348 - 2025-08-12
- FDA Inspection 1040233 - 2018-02-06
- FDA Inspection 980924 - 2016-07-12
- FDA Inspection 853289 - 2013-10-11
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