Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 33.3% decrease from the number of companies cited in the previous quarter.
Of the seven citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.
All of the companies cited were involved in the Devices sector.
Both companies cited should take voluntary actions to correct their managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Mannkind Corporation | Devices | 10/03/2024 | Design validation - user needs and intended uses |
| Mannkind Corporation | Devices | 10/03/2024 | Design changes - Lack of or Inadequate Procedures |
| Mannkind Corporation | Devices | 10/03/2024 | Lack of or inadequate procedures |
| Mannkind Corporation | Devices | 10/03/2024 | Lack of or inadequate complaint procedures |
| Mannkind Corporation | Devices | 10/03/2024 | Sampling plans |
| Tecomet, Inc. | Devices | 11/12/2024 | Lack of procedures, or not maintained |
| Tecomet, Inc. | Devices | 11/12/2024 | Lack of or inadequate procedures |
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