FDA Inspection
ANI Pharmaceuticals Canada, Inc.ANI Pharmaceuticals Canada, Inc. – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns ANI Pharmaceuticals Canada, Inc., with an inspection on December 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Ivy E. Sweeney (Issuing Officer)
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ID · 22d503db-17e6-4e2e-9793-da50a16b530c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997351
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of ANI Pharmaceuticals Canada, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2019 | 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 1197890 - 2023-02-17
- FDA Inspection 1096666 - 2019-06-07
- FDA Inspection 866138 - 2014-01-24
- FDA Inspection 635624 - 2009-12-18
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