Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 69.2% decrease from the number of companies cited in the previous year.
Of the 13 citations issued, the most common citation was 'A qualified container closure inspection person did not record the observations made of the top seam of a can randomly selected from each seaming head and the container closures at intervals of sufficient frequency to ensure proper closure'.
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 |
---|---|---|---|
Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Personnel |
Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Plant construction and design |
Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Sanitary facilities and controls |
GFS Chemicals, Inc. | Devices | 11/17/2023 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
Mars Petcare US, Inc. | Food and Cosmetics | 01/23/2023 | Frequency: visual closure examinations, record |
Mars Petcare US, Inc. | Veterinary | 01/23/2023 | Frequency: visual closure examinations, record |
Safecor Health, LLC | Drugs | 09/01/2023 | Identity Testing of Each Component |
Safecor Health, LLC | Drugs | 09/01/2023 | Absence of Written Procedures |
Safecor Health, LLC | Drugs | 09/01/2023 | Changes to Procedures Not Reviewed, Approved |
Safecor Health, LLC | Drugs | 09/01/2023 | Reprocessing/quality control unit |
Safecor Health, LLC | Drugs | 09/01/2023 | Sample size - test intervals |
Safecor Health, LLC | Drugs | 09/01/2023 | Written records kept in individual logs |
Safecor Health, LLC | Drugs | 09/01/2023 | Investigations of discrepancies, failures |