Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is a 50% increase over the number of companies cited in the previous month.
The citations in the county include:
- An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
- An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- Corrective and preventive action activities and/or results have not been adequately documented.
Most of the companies cited were involved in the Devices sector.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Report of Death or Serious Injury |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Individual Report of Malfunction |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Documentation |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Investigation of device failures |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Personnel |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Sanitary operations - Plant sanitation |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Toxic chemicals - Identified, held, stored |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Pest control |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Sanitary facilities and controls |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Manufacturing, processing, packing, holding - Controls |
| EUSA Global, LLC | Devices | 03/22/2024 | Management review - defined interval, sufficient frequency |
| EUSA Global, LLC | Devices | 03/22/2024 | Nonconforming product, Lack of or inadequate procedures |
| EUSA Global, LLC | Devices | 03/22/2024 | Lack of or inadequate procedures for labeling |
| EUSA Global, LLC | Devices | 03/22/2024 | Lack of or inadequate complaint procedures |
Alerts Sign-up