# FDA 483 - Mendell Inc - August 03, 2022

Source: https://www.keypedia.com/records/483/mendell-inc/e65cf465-e283-4c52-b227-2fc75f0fd8df

> FDA 483 for Mendell Inc on August 03, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mendell Inc
- Inspection Date: 2022-08-03
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Mendell Inc, a contract manufacturer in Lakeville, MN, was cited with a Form FDA-483 due to significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, specifically concerning the verification of effectiveness and adherence to established timelines. Additionally, the firm failed to adequately maintain records of changes to documents.

## Related Documents

- [483 - 2025-05-30](https://www.keypedia.com/records/483/mendell-inc/d52f3183-602a-45df-8886-a68cfd314cfe)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/joseph-d-gong/c1079a56-5f84-4e0d-9f76-9dc1187e588a)

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