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 a 60% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- Drug products failing to meet established specifications are not rejected.
- There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
The companies cited were involved in either Drugs or Food and Cosmetics sectors.
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 |
---|---|---|---|
Bosch Baking, Inc. | Food and Cosmetics | 10/25/2024 | Personnel |
Bosch Baking, Inc. | Food and Cosmetics | 10/25/2024 | Plant construction and design |
Bosch Baking, Inc. | Food and Cosmetics | 10/25/2024 | Pest control |
Bosch Baking, Inc. | Food and Cosmetics | 10/25/2024 | Manufacturing, processing, packing, holding - Controls |
Bosch Baking, Inc. | Food and Cosmetics | 10/25/2024 | Storage and Distribution |
Bosch Baking, Inc. | Food and Cosmetics | 10/25/2024 | Hazard analysis - Conducted |
Wellington Foods | Drugs | 10/11/2024 | Absence of Written Procedures |
Wellington Foods | Drugs | 10/11/2024 | Failing drug products not rejected |
Wellington Foods | Drugs | 10/11/2024 | Investigations of discrepancies, failures |