# FDA 483 - Epien Medical, Inc - December 06, 2018

Source: https://www.globalkeysolutions.net/records/483/epien-medical-inc/536a3d29-c626-44b9-b395-0df1068771e7

> FDA 483 for Epien Medical, Inc on December 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Epien Medical, Inc
- Inspection Date: 2018-12-06
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Epien Medical, Inc. in White Bear Lake, MN, was inspected from November 26, 2018, to December 6, 2018, and received a Form 483 with three observations. The observations highlight deficiencies in quality control for raw materials, including a failure to establish supplier reliability for Certificates of Analysis and a lack of incoming component identity testing. Additionally, the firm's equipment cleaning procedures were found to be inadequate, lacking evaluation of effectiveness and specific instructions.

## Related Documents

- [483 - 2025-08-28](https://www.globalkeysolutions.net/records/483/epien-medical-inc/ab26a95c-a064-432f-b3e4-33bb5a2d3419)

## Related Officers

- [Deputy Commissioner for Foods](https://www.globalkeysolutions.net/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)

Company: https://www.globalkeysolutions.net/companies/epien-medical-inc/448146b7-762c-4524-a71f-3308726efffd

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d