# FDA 483 - RePharm LLC - Unknown Date

Source: https://www.keypedia.com/records/483/repharm-llc/c39fa3b8-2f35-45e2-aa87-c0b6513a7a46

> FDA 483 for RePharm LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RePharm LLC
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: RePharm LLC, a drug repacker in Riverside, MO, received a Form 483 with two repeat observations during an FDA inspection. The firm failed to follow its written procedures, with many SOPs being generic, inaccurate, or not reflecting actual processes, and lacked validation protocols for critical equipment. Additionally, the inspection revealed that the firm did not adequately test drug product batches to determine appropriate expiration dates, showing deficiencies in stability testing, supplier qualification, and packaging material shelf-life management.

## Related Documents

- [483 - 2019-07-03](https://www.keypedia.com/records/483/repharm-llc/33a71cfd-1092-4182-8cc1-7f312c944891)

## Related Officers

- [Gretchen L. Trendel](https://www.keypedia.com/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)

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