Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 25% increase over the number of companies cited in the previous quarter.
Of the 12 citations issued, the most common citations were 'An onsite audit of a foreign supplier did not consider an applicable food safety regulation' and 'You did not implement your sanitation preventive control, monitoring and corrective action procedures'.
Most of the companies cited were involved in the Food and Cosmetics 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 |
---|---|---|---|
Bobalu, LLC | Food and Cosmetics | 11/30/2023 | Document review entity's hazard analysis |
Bobalu, LLC | Food and Cosmetics | 11/30/2023 | Evaluation - performance, risk |
Bobalu, LLC | Food and Cosmetics | 11/30/2023 | Approved supplier procedures - importer established |
Bobalu, LLC | Food and Cosmetics | 11/30/2023 | Verification activity - appropriate |
Bobalu, LLC | Food and Cosmetics | 11/30/2023 | Audit - food safety regulation, plan |
Calavo Growers, Inc. | Food and Cosmetics | 10/31/2023 | Audit - food safety regulation, plan |
Gills Onions, LLC | Food and Cosmetics | 11/22/2023 | Sanitation preventive controls - Implement |
Gills Onions, LLC | Veterinary | 11/22/2023 | Sanitation preventive controls - Implement |
Natren, Inc. | Drugs | 11/02/2023 | Approve or reject components, products |
Natren, Inc. | Drugs | 11/02/2023 | Components withheld from use pending release |
Natren, Inc. | Drugs | 11/02/2023 | Homeopathic drugs, assessment of stability |
WJL Distributors, Inc. | Food and Cosmetics | 10/27/2023 | Develop FSVP |