ANI Pharmaceuticals, Inc.
FDA inspection history in Baudette, Minnesota, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Baudette, Minnesota.
- 2022The longest 483 on file: 6 observations over 6 pages at Baudette, Minnesota.
Cited most
Across all ANI Pharmaceuticals observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.188Batch production and control records1
The complete ANI Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Baudette, Minnesota
Two Form 483s · 2022 to 2024 · 6 observations
Latest: Form 483, Dec 6, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-06 | 483 Form 483 | Baudette, Minnesota | — | $99 |
| 2022-11-18 | 483 Form 483 | Baudette, Minnesota | 6 | $99 |
Investigators on these documents
FEI number 2111358 · most recent document Dec 6, 2024
About ANI Pharmaceuticals, Inc.
How many FDA Form 483s has ANI Pharmaceuticals, Inc. received?
FDA Intel has 2 Form 483s on file for ANI Pharmaceuticals, Inc.; the most recent is dated Dec 6, 2024.
When was ANI Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for ANI Pharmaceuticals, Inc. is a Form 483 dated Dec 6, 2024, for the site in Baudette, Minnesota.
What did FDA cite at ANI Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for ANI Pharmaceuticals, Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times.