Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the city were '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' and 'Procedures for corrective and preventive action have not been adequately established'.
The company cited should take a voluntary action to correct its 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 |
---|---|---|---|
Weinert Fiber Optics, Inc. | Devices | 01/13/2023 | Report of Death or Serious Injury |
Weinert Fiber Optics, Inc. | Devices | 01/13/2023 | Lack of or inadequate procedures |