# FDA 483 - Mendell Inc - May 30, 2025

Source: https://www.keypedia.com/records/483/mendell-inc/d52f3183-602a-45df-8886-a68cfd314cfe

> FDA 483 for Mendell Inc on May 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mendell Inc
- Inspection Date: 2025-05-30
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Mendell Machine and Manufacturing LLC, a manufacturer in Lakeville, MN, received a Form FDA-483 citing two observations. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding documentation of CAPA effectiveness and risk assessments. Additionally, the company did not properly maintain records of changes to its critical inspection plans.

## Related Documents

- [483 - 2022-08-03](https://www.keypedia.com/records/483/mendell-inc/e65cf465-e283-4c52-b227-2fc75f0fd8df)

## Related Officers

- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/mendell-inc/41f1a305-5b74-428b-a432-0a29801a25f9

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