FDA Inspection
Delpharm Boucherville Canada, Inc.Delpharm Boucherville Canada, Inc. – FDA Inspection, Jan 26, 2024
Record Details
This FDA Inspection record concerns Delpharm Boucherville Canada, Inc., with an inspection on January 26, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e3043917-b0ed-47e4-8e77-3dabfc790f1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228759
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Delpharm Boucherville Canada, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 12, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 4, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Delpharm Boucherville Canada, Inc.
- FDA Inspection 1121358 - 2020-02-11
- FDA Inspection 1057031 - 2018-06-12
- FDA Inspection 982638 - 2016-08-09
- FDA Inspection 855260 - 2013-10-22
- FDA Inspection 743413 - 2011-08-04
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