# FDA 483 - ANI Pharmaceuticals, Inc. - November 18, 2022

Source: https://www.keypedia.com/records/483/ani-pharmaceuticals-inc/472f758c-3a86-486f-a0eb-4bdbf0d0f130

> FDA 483 for ANI Pharmaceuticals, Inc. on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ANI Pharmaceuticals, Inc.
- Inspection Date: 2022-11-18
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: ANI Pharmaceuticals, Inc. in Baudette, MN, was inspected by the FDA from November 14-18, 2022, resulting in a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, production procedures, sanitation, and complaint handling. Key issues included inadequate investigations into product discrepancies, failure to follow environmental control SOPs, and improper container testing.

## Related Documents

- [EIR - 2022-11-18](https://www.keypedia.com/records/eir/ani-pharmaceuticals-inc/20b0a03d-6de6-4404-a803-eda321e23de6)
- [483 - Unknown Date](https://www.keypedia.com/records/483/ani-pharmaceuticals-inc/b826b54b-c8eb-45aa-93b5-a0a7190bc88a)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)
- [Anders Evenson](https://www.keypedia.com/people/anders-evenson/a37224ef-88c8-47ed-83ba-421695dd2228)

Company: https://www.keypedia.com/companies/ani-pharmaceuticals-inc/8ba70b88-4d7d-4766-8dda-f4b44b5c35e3

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d