# FDA 483 - LISI MEDICAL Remmele, Inc - May 01, 2025

Source: https://www.keypedia.com/records/483/lisi-medical-remmele-inc/2e8982eb-dc54-4bfe-b06d-b794d5d4da63

> FDA 483 for LISI MEDICAL Remmele, Inc on May 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LISI MEDICAL Remmele, Inc
- Inspection Date: 2025-05-01
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: LISI MEDICAL Remmele, Inc. in Coon Rapids, MN, a medical device manufacturer, was cited for two significant issues during an FDA inspection. The firm's procedures for corrective and preventive actions were found inadequate, failing to ensure the verification or validation of action effectiveness. Additionally, the company's training procedures did not consistently identify essential training needs or ensure employees were properly trained for their assigned responsibilities, including critical quality inspection roles.

## Related Documents

- [483 - 2022-07-12](https://www.keypedia.com/records/483/lisi-medical-remmele-inc/ec5b71b2-dce3-42d2-8c07-a9af7d723cfa)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/lisi-medical-remmele-inc/5db0d935-dd79-4f93-9b48-cb429353e242

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