FDA Inspection
Delpharm Boucherville Canada, Inc.Delpharm Boucherville Canada, Inc. – FDA Inspection, Oct 22, 2013
Record Details
This FDA Inspection record concerns Delpharm Boucherville Canada, Inc., with an inspection on October 22, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 22, 2013
- Product Type
- Drugs
View Company Profile
ID · 105e1075-1707-49c3-b41f-b7a475eadeb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855260
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Delpharm Boucherville Canada, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
| August 4, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Delpharm Boucherville Canada, Inc.
- FDA Inspection 1228759 - 2024-01-26
- FDA Inspection 1121358 - 2020-02-11
- FDA Inspection 1057031 - 2018-06-12
- FDA Inspection 982638 - 2016-08-09
- FDA Inspection 743413 - 2011-08-04
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