ANI Pharmaceuticals, Inc.
Form 483 issued November 18, 2022 · Baudette, Minnesota
- Inspection
- Jan 14 – Nov 18, 2022
- Investigators
- Anders W. Evenson· Michele Perry Williams
- Observations
- 6
- Pages
- 6
- FEI number
- 2111358
In short: On November 18, 2022, FDA issued a Form 483 with 6 observations to ANI Pharmaceuticals, Inc. in Baudette, Minnesota (FEI 2111358) after an inspection that ran Jan 14 – Nov 18, 2022. The investigators were Anders W. Evenson and Michele Perry Williams. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Written production and process control procedures are not followed in the execution of production and process…
- 03
Containers and closures are not tested for conformance with…
- 04
Written procedures for sanitation…
This inspection in context
Anders W. Evenson
3 documents · 2022–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmANI Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ANI Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected ANI Pharmaceuticals, Inc.?
Anders W. Evenson and Michele Perry Williams are named on this Form 483, for the inspection of Jan 14 – Nov 18, 2022. Each investigator has a profile showing what they cite most.
When was ANI Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 14 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for ANI Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.