ANI Pharmaceuticals, Inc.
Form 483 issued December 6, 2024 · Baudette, Minnesota
- Observations
- 8
- Pages
- 8
- FEI number
- 2111358
In short: On December 6, 2024, FDA issued a Form 483 with 8 observations to ANI Pharmaceuticals, Inc. in Baudette, Minnesota (FEI 2111358). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
The identity of each component of a drug product is not verified by conducting a(b) (4)…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at ANI Pharmaceuticals, Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was ANI Pharmaceuticals, Inc. inspected by FDA?
This Form 483 is dated December 6, 2024.
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.