FDA Inspection
Duchesnay Inc.Duchesnay Inc. – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Duchesnay Inc., with an inspection on March 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a0b2b2b1-250a-4d80-9f4c-5d9c7d17c5e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084594
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Duchesnay Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Duchesnay Inc.
- FDA Inspection 1222804 - 2023-10-27
- FDA Inspection 961818 - 2016-02-25
- FDA Inspection 847906 - 2013-08-22
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