# FDA 483 - AML Riverside, LLC - August 14, 2023

Source: https://www.globalkeysolutions.net/records/483/aml-riverside-llc/a6890ceb-9cdc-4145-85aa-65b4feb95156

> FDA 483 for AML Riverside, LLC on August 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AML Riverside, LLC
- Inspection Date: 2023-08-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: AML Riverside, LLC, a drug manufacturer in Fort Dodge, IA, was cited for significant quality control deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate product discrepancies such as empty finished product samples, inadequate labeling of processing equipment, and a lack of established procedures for preventing objectionable microorganisms. These issues indicate a need for improved adherence to good manufacturing practices.

## Related Documents

- [483 - 2019-04-03](https://www.globalkeysolutions.net/records/483/aml-riverside-llc/4f222a39-4e05-4093-97e2-ffa41e798a4a)

## Related Officers

- [Soyinka S. Eneng](https://www.globalkeysolutions.net/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)
- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.globalkeysolutions.net/companies/aml-riverside-llc/1e839f8a-1cf4-48cd-90e1-62e3a2de0ca6

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8
