Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- A validated process was not revalidated when changes or process deviations occurred.
- You did not ensure that all individuals who manufacture, process, pack, or hold animal food are qualified to perform their assigned duties.
- You did not clean and maintain utensils and equipment in a manner that protects against contamination.
Most of the companies cited were involved in the Drugs 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.
According to its website, 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.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Acceleration Laboratory Services, Inc. | Drugs | 07/11/2024 | Calibration - at intervals, written program, remedial action |
Acceleration Laboratory Services, Inc. | Drugs | 07/11/2024 | No written record of investigation |
Hansen Mueller Company Kansas City | Veterinary | 05/03/2024 | Individual/Employee Qualifications |
Hansen Mueller Company Kansas City | Veterinary | 05/03/2024 | Sanitation |
Hansen Mueller Company Kansas City | Veterinary | 05/03/2024 | Protein blenders, feed manufacturers, distributors |
Hansen Mueller Company Kansas City | Veterinary | 05/03/2024 | Separate equipment and facilities or adequate cleanout |
Nostrum Laboratories, Inc. | Drugs | 09/20/2024 | Failure to develop written procedures |
Nostrum Laboratories, Inc. | Drugs | 09/20/2024 | Late submission of 15-day report |
Southwest Technologies, Inc. | Devices | 05/16/2024 | Process changes - review, evaluation and revalidation |