# FDA 483 - EPM Packaging, Inc. - August 22, 2025

Source: https://www.keypedia.com/records/483/epm-packaging-inc/2bea6a1b-b956-435a-8354-8ebbc480a04e

> FDA 483 for EPM Packaging, Inc. on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EPM Packaging, Inc.
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: EPM Packaging, Inc. in Lexington, NE, received five observations during an FDA inspection, primarily concerning inadequate separation of penicillin packaging operations from other drug products. The firm was cited for significant cross-contamination risks due to shared HVAC systems, personnel access, and a lack of validated cleaning and testing procedures. Additionally, the inspection revealed a critical absence of essential written procedures for production controls and quality unit responsibilities.

## Related Documents

- [483 - 2023-01-12](https://www.keypedia.com/records/483/epm-packaging-inc/85005749-ebb0-458d-b41a-84e25d43e0dc)
- [483 - 2025-06-13](https://www.keypedia.com/records/483/epm-packaging-inc/cbaa40f6-2b5e-476b-9006-28571da28e26)

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Sangeeta Patel](https://www.keypedia.com/people/sangeeta-patel/9329b3d6-c2a8-4691-ba19-67da07ed419e)

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