# FDA 483 - EPM Packaging, Inc. - January 12, 2023

Source: https://www.globalkeysolutions.net/records/483/epm-packaging-inc/85005749-ebb0-458d-b41a-84e25d43e0dc

> FDA 483 for EPM Packaging, Inc. on January 12, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EPM Packaging, Inc.
- Inspection Date: 2023-01-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: EPM Packaging Inc, a repackager/relabeler in Lexington, NE, was inspected by the FDA from January 10-12, 2023. The inspection revealed significant deficiencies in batch production and control records, inadequate sampling and supplier qualification for containers and closures, and a lack of established written procedures for production, process controls, equipment qualification, and change management. These issues indicate a general lack of control over critical manufacturing processes.

## Related Documents

- [483 - 2025-06-13](https://www.globalkeysolutions.net/records/483/epm-packaging-inc/cbaa40f6-2b5e-476b-9006-28571da28e26)
- [483 - 2025-08-22](https://www.globalkeysolutions.net/records/483/epm-packaging-inc/2bea6a1b-b956-435a-8354-8ebbc480a04e)

## Related Officers

- [Torrey M. Ward](https://www.globalkeysolutions.net/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.globalkeysolutions.net/companies/epm-packaging-inc/1fc7840f-3f4b-4e43-9b17-df107091ec44

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