# FDA 483 - Ash Stevens LLC - July 09, 2026

Source: https://www.keypedia.com/records/483/ash-stevens-llc/1605c765-13c5-46ed-bafa-96a3bebfa97a

> FDA 483 for Ash Stevens LLC on July 09, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ash Stevens LLC
- Inspection Date: 2026-07-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Ash Stevens Inc. in Riverview, MI, revealed two significant observations related to their API manufacturing operations. The firm failed to implement adequate procedures for handling approved solvents during dispensing, posing a risk of cross-contamination. Additionally, written procedures for the preventative maintenance of production equipment were not followed, resulting in missing and incomplete documentation.

## Related Documents

- [483 - 2026-12-06](https://www.keypedia.com/records/483/ash-stevens-llc/395b4e1a-437f-4f97-ae41-d4cb2d968d88)
- [483 - 2004-11-04](https://www.keypedia.com/records/483/ash-stevens-llc/9cd87bda-128b-42a9-87a4-e73103e5e5cc)
- [483 - 2010-12-22](https://www.keypedia.com/records/483/ash-stevens-llc/7392806d-9ab8-496e-8b43-9c8f4b222bf1)
- [EIR - 2022-11-04](https://www.keypedia.com/records/eir/ash-stevens-llc/446eb510-5463-4bf1-bff4-c1b92c774ea0)

## Related Officers

- [Investigator](https://www.keypedia.com/people/caroline-h-le/9cafc7f3-f426-458c-8f62-5a201030e4a8)

Company: https://www.keypedia.com/companies/ash-stevens-llc/52224de1-83ac-4289-a4f7-7bc9f6813f03

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0