# FDA 483 - AML Riverside, LLC - April 03, 2019

Source: https://www.keypedia.com/records/483/aml-riverside-llc/4f222a39-4e05-4093-97e2-ffa41e798a4a

> FDA 483 for AML Riverside, LLC on April 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AML Riverside, LLC
- Inspection Date: 2019-04-03
- 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, received a Form 483 citing significant deficiencies during an FDA inspection. The observations included a lack of strict control over drug product labeling, failures within the quality control unit regarding overdue CAPA items and product trending, and non-adherence to established laboratory control mechanisms for investigative testing. These issues indicate a need for improved adherence to Good Manufacturing Practices.

## Related Documents

- [483 - 2023-08-14](https://www.keypedia.com/records/483/aml-riverside-llc/a6890ceb-9cdc-4145-85aa-65b4feb95156)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)

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

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