FDA Inspection
ANI Pharmaceuticals, Inc.ANI Pharmaceuticals, Inc. – FDA Inspection, Jan 29, 2010
Record Details
This FDA Inspection record concerns ANI Pharmaceuticals, Inc., with an inspection on January 29, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ANI Pharmaceuticals, Inc.
- Inspection Date
- January 29, 2010
- Product Type
- Drugs
View Company Profile
ID · c065fcb3-d13c-439e-9b1f-d46049b5f39b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 643297
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.160(b)Scientifically sound laboratory controls
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ANI Pharmaceuticals, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2024 | Not classified | Minneapolis District Office | |
| November 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 18, 2017 | Not classified | Minneapolis District Office | |
| July 28, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for ANI Pharmaceuticals, Inc.
- FDA Inspection 1250465 - 2024-12-06
- FDA Inspection 1191619 - 2022-11-18
- FDA Inspection 1089435 - 2019-04-12
- FDA Inspection 1016454 - 2017-05-18
- FDA Inspection 983493 - 2016-07-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.