Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is a 100% increase over the number of companies cited in the previous year.
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.
- Corrective and preventive action activities and/or results have not been adequately documented.
- Complaint files are not adequately maintained.
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 |
---|---|---|---|
OsteoCentric Technologies, Inc. | Devices | 11/13/2023 | Report of Death or Serious Injury |
OsteoCentric Technologies, Inc. | Devices | 11/13/2023 | Documentation |
OsteoCentric Technologies, Inc. | Devices | 11/13/2023 | Complaints |
Zollingers Fruit & Tree Farm, Inc. | Food and Cosmetics | 11/09/2023 | Hazard analysis - written - elements |