FDA Inspection
ANI Pharmaceuticals Canada, Inc.ANI Pharmaceuticals Canada, Inc. – FDA Inspection, Feb 17, 2023
Record Details
This FDA Inspection record concerns ANI Pharmaceuticals Canada, Inc., with an inspection on February 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7924e187-3fd5-44ff-aeb4-09be81c25b48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1197890
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of ANI Pharmaceuticals Canada, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ANI Pharmaceuticals Canada, Inc.
- FDA Inspection 1096666 - 2019-06-07
- FDA Inspection 997351 - 2016-12-09
- FDA Inspection 866138 - 2014-01-24
- FDA Inspection 635624 - 2009-12-18
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