# FDA 483 - RePharm LLC - July 03, 2019

Source: https://www.keypedia.com/records/483/repharm-llc/33a71cfd-1092-4182-8cc1-7f312c944891

> FDA 483 for RePharm LLC on July 03, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: RePharm LLC
- Inspection Date: 2019-07-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Repharm LLC, a drug repacker and relabeler in Riverside, MO, was cited for significant quality control and GMP deficiencies during an FDA inspection. Observations included a lack of quality unit review and approval for batch records and SOPs, inadequate employee training, and a failure to investigate discrepancies and out-of-specification results. Additionally, the firm lacked scientific justification for expiration dates and failed to qualify equipment or document label inspections.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/repharm-llc/c39fa3b8-2f35-45e2-aa87-c0b6513a7a46)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/repharm-llc/d39558e4-a44b-43c5-b75c-563dee1dd778

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