# FDA 483 - Legacy Pharmaceutical Packaging LLC - June 20, 2023

Source: https://www.keypedia.com/records/483/legacy-pharmaceutical-packaging-llc/1e6d340f-d04a-41c7-b635-6e03d603e170

> FDA 483 for Legacy Pharmaceutical Packaging LLC on June 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legacy Pharmaceutical Packaging LLC
- Inspection Date: 2023-06-20
- Product Type: device
- Office Name: Center for Devices and Radiological Health
- Summary: Legacy Pharmaceutical Packaging LLC, a medical device repacker/relabeler in Earth City, MO, was cited for two significant issues during an FDA inspection. The firm failed to establish adequate procedures for corrective and preventive actions, as evidenced by an ineffective action item related to missing medical device components. Additionally, the inspection found that software used in the quality system, specifically for labeling with QR codes, had not been adequately validated for its intended use since 2011.

## Related Documents

- [483 - 2019-01-25](https://www.keypedia.com/records/483/legacy-pharmaceutical-packaging-llc/02e153b7-4c6e-43b5-b9cf-afac93766658)
- [EIR - 2019-01-25](https://www.keypedia.com/records/eir/legacy-pharmaceutical-packaging-llc/3d106d77-6536-4004-995c-813ba563faa7)
- [483 - 2020-01-16](https://www.keypedia.com/records/483/legacy-pharmaceutical-packaging-llc/6b58df57-672a-4311-a749-d866b42191ea)
- [483 - 2020-01-16](https://www.keypedia.com/records/483/legacy-pharmaceutical-packaging-llc/b33ccf68-4650-40d6-9363-95b5a614f95a)
- [483 - 2022-04-27](https://www.keypedia.com/records/483/legacy-pharmaceutical-packaging-llc/75edfb0b-91b7-433b-8a62-206fbce3b285)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7