# FDA 483 - Mannkind Corporation - September 07, 2018

Source: https://www.keypedia.com/records/483/mannkind-corporation/e39a4b19-b700-46de-b46c-c9748dc32cb1

> FDA 483 for Mannkind Corporation on September 07, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mannkind Corporation
- Inspection Date: 2018-09-07
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Valeritas, Incorporated in Marlborough, MA, revealed significant deficiencies in their quality system. The firm lacked written Medical Device Reporting (MDR) procedures, failed to submit numerous adverse event reports within the required timeframe, and inadequately maintained complaint files. Additionally, issues were noted with design risk analysis documentation and the inclusion of Unique Device Identifier (UDI) information in device history records.

## Related Documents

- [483 - 2024-10-03](https://www.keypedia.com/records/483/mannkind-corporation/cd81e0e2-45bb-49f1-94e5-e39582c2a3f9)

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94