# FDA 483 - Mannkind Corporation - October 03, 2024

Source: https://www.keypedia.com/records/483/mannkind-corporation/cd81e0e2-45bb-49f1-94e5-e39582c2a3f9

> FDA 483 for Mannkind Corporation on October 03, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mannkind Corporation
- Inspection Date: 2024-10-03
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Mannkind Corporation, a manufacturer of the V-Go wearable insulin delivery device, identified significant deficiencies in their quality system. Observations included inadequate statistical rationale for sampling, insufficient design change verification for water resistance, and a failure to validate the device's conformity to user needs regarding adhesion. Additionally, the firm's corrective and preventive action procedures were not fully implemented or verified, and complaint investigations were found to be inadequate, leading to potential patient safety risks.

## Related Documents

- [483 - 2018-09-07](https://www.keypedia.com/records/483/mannkind-corporation/e39a4b19-b700-46de-b46c-c9748dc32cb1)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/mannkind-corporation/c4fe67e8-1e0c-48fb-9847-e8a284409d8c

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144