# FDA 483 - Legacy Pharmaceutical Packaging LLC - April 27, 2022

Source: https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/75edfb0b-91b7-433b-8a62-206fbce3b285

> FDA 483 for Legacy Pharmaceutical Packaging LLC on April 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legacy Pharmaceutical Packaging LLC
- Inspection Date: 2022-04-27
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Legacy Pharmaceutical Packaging, LLC. in Earth City, MO, received an FDA Form 483 for significant deficiencies in its operations. The inspection revealed inadequate production and process controls, including unvalidated reprocessing procedures and incomplete batch records. Furthermore, the firm failed to ensure proper employee training and conducted insufficient investigations into batch failures and product contamination.

## Related Documents

- [483 - 2019-01-25](https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/02e153b7-4c6e-43b5-b9cf-afac93766658)
- [483 - 2020-01-16](https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/b33ccf68-4650-40d6-9363-95b5a614f95a)
- [483 - 2020-01-16](https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/6b58df57-672a-4311-a749-d866b42191ea)
- [WARNING_LETTER - 2022-04-27](https://www.globalkeysolutions.net/records/warning_letter/legacy-pharmaceutical-packaging-llc/f5aa9520-e9a4-4050-99ff-c9f391ccc50d)
- [483 - 2023-06-30](https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/503cd539-6ac2-4cdf-96ef-ee2035fa6c8e)

## Related Officers

- [Matthew M. Schuckmann](https://www.globalkeysolutions.net/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

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

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79