Drug factory · FDA FEI 2111358
ANI Pharmaceuticals, Inc.
210 Main Street West, Baudette, MN, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 6, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
13 drug inspections on record since 2010: 6 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Griseofulvin | Makes it and packages it | Amneal Pharmaceuticals | 0115-1724, 0115-1725 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 6, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 18, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 12, 2019 | No problems found | Bioresearch Monitoring | — |
| Jul 28, 2016 | No problems found | Drug Quality Assurance | 2 |
| Jul 28, 2016 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Sep 27, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 27, 2013 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jan 6, 2012 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | — |
| Sep 16, 2011 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | — |
| Sep 16, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 28, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 28, 2016 inspection
- Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. - Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Jan 29, 2010 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Registered with FDA for: analysis; label; manufacture; pack.