James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is an increase over the number of companies cited in the previous year.
Of the 11 citations issued, the most common citations were 'Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination' and 'Your hazard analysis did not identify a hazard that required a preventive control'.
Most of the companies cited were involved in the Food and Cosmetics sector.
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 |
---|---|---|---|
M. A. & Sons, Incorporated | Food and Cosmetics | 11/16/2023 | Equipment and utensils - Design and maintenance |
M. A. & Sons, Incorporated | Food and Cosmetics | 11/16/2023 | Hazard analysis - Identification of hazard |
M. A. & Sons, Incorporated | Veterinary | 11/16/2023 | Equipment and utensils - Design and maintenance |
M. A. & Sons, Incorporated | Veterinary | 11/16/2023 | Hazard analysis - Identification of hazard |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Hazard analysis written |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Evaluation - performance, risk |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Supplier verification - establish written procedures |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Verification activity assurance |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Verification activity frequency |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Verification activity before import, periodically |
San Martin Enterprises, LLC | Food and Cosmetics | 03/23/2023 | Record - translate to English |