# FDA 483 - EPM Packaging, Inc. - June 13, 2025

Source: https://www.keypedia.com/records/483/epm-packaging-inc/cbaa40f6-2b5e-476b-9006-28571da28e26

> FDA 483 for EPM Packaging, Inc. on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EPM Packaging, Inc.
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: EPM Packaging, Inc. in Lexington, NE, a repackager and relabeler, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies in facility separation for penicillin and other drug products, cross-contamination prevention, data integrity, documentation, equipment qualification, employee training, equipment cleaning, pest control records, and quality control unit procedures. These issues indicate a lack of adequate controls to ensure drug product quality and prevent contamination.

## Related Documents

- [483 - 2023-01-12](https://www.keypedia.com/records/483/epm-packaging-inc/85005749-ebb0-458d-b41a-84e25d43e0dc)
- [483 - 2025-08-22](https://www.keypedia.com/records/483/epm-packaging-inc/2bea6a1b-b956-435a-8354-8ebbc480a04e)

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [JeanClaude Garay](https://www.keypedia.com/people/jeanclaude-garay/62e387aa-73d3-4f69-8cc2-5607b7963d7f)

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

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