# FDA 483 - Legacy Pharmaceutical Packaging LLC - January 16, 2020

Source: https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/6b58df57-672a-4311-a749-d866b42191ea

> FDA 483 for Legacy Pharmaceutical Packaging LLC on January 16, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legacy Pharmaceutical Packaging LLC
- Inspection Date: 2020-01-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Legacy Pharmaceutical Packaging LLC, a medical device contract manufacturer in Earth City, MO, was cited for multiple deficiencies related to its quality system. The inspection revealed significant issues with process validation, particularly concerning its vision system for packaging, as well as inadequate documentation of rework, nonconforming product control, equipment maintenance, and complaint handling procedures. These observations indicate a lack of robust quality controls and documentation practices.

## 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 - 2022-04-27](https://www.globalkeysolutions.net/records/483/legacy-pharmaceutical-packaging-llc/75edfb0b-91b7-433b-8a62-206fbce3b285)
- [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

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

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

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