# FDA 483 - Legacy Pharmaceutical Packaging LLC - January 25, 2019

Source: https://www.keypedia.com/records/483/legacy-pharmaceutical-packaging-llc/02e153b7-4c6e-43b5-b9cf-afac93766658

> FDA 483 for Legacy Pharmaceutical Packaging LLC on January 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legacy Pharmaceutical Packaging LLC
- Inspection Date: 2019-01-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Legacy Pharmaceutical Packaging LLC, a contract packager and repackager in Earth City, MO, was cited for significant deficiencies in its employee training program. The firm failed to provide required GMP training in 2017 and 2018, and an untrained employee was involved in an operational error leading to inconsistent tablet counts. These issues indicate a systemic failure to adhere to personnel training requirements and current good manufacturing practices.

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## Related Officers

- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)
- [investigator](https://www.keypedia.com/people/ana-paula-p-sandee/7c96feb2-cb1d-4808-a65c-eafba38c3b2d)

Company: https://www.keypedia.com/companies/legacy-pharmaceutical-packaging-llc/c20cc0b4-a180-4bd8-be9b-9b4c62b26e8f

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