Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is a 50% increase over the number of companies cited in the previous quarter.
Of the 14 citations issued, the most common citations were 'Personnel training is not documented' and 'Corrective and preventive action activities and/or results have not been adequately documented'.
Most of the companies cited were involved in the Devices sector.
All of the 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 |
|---|---|---|---|
| Galli Produce Company, Inc. | Food and Cosmetics | 08/20/2024 | Plant construction and design |
| Galli Produce Company, Inc. | Food and Cosmetics | 08/20/2024 | Pest control |
| Galli Produce Company, Inc. | Food and Cosmetics | 08/20/2024 | Supply-chain program - Assurance (Adequate) |
| Imedrix, Inc. | Devices | 07/24/2024 | Records not kept |
| Imedrix, Inc. | Devices | 07/24/2024 | Management review - defined interval, sufficient frequency |
| Imedrix, Inc. | Devices | 07/24/2024 | Training records |
| Imedrix, Inc. | Devices | 07/24/2024 | Design Validation - Risk analysis not performed/inadequate |
| Imedrix, Inc. | Devices | 07/24/2024 | Procedures not adequately established or maintained |
| Imedrix, Inc. | Devices | 07/24/2024 | Acceptable supplier records, inadequate records |
| Imedrix, Inc. | Devices | 07/24/2024 | Documentation |
| Imedrix, Inc. | Devices | 07/24/2024 | Complaints |
| North Coast Medical, Inc. | Devices | 08/02/2024 | Training records |
| North Coast Medical, Inc. | Devices | 08/02/2024 | Documentation |
| North Coast Medical, Inc. | Devices | 08/02/2024 | Review and evaluation for investigation |
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