Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not employ sufficient qualified personnel to perform all operations in the manufacture, processing, packing and holding of each infant formula.
- You did not clean, sanitize, and maintain equipment and utensils used in the manufacture of infant formula at regular intervals.
- You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
The company cited should take a voluntary action to correct its 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 |
---|---|---|---|
Perrigo Wisconsin, LLC | Food and Cosmetics | 11/29/2023 | Qualified personnel to perform operations |
Perrigo Wisconsin, LLC | Food and Cosmetics | 11/29/2023 | Clean, sanitize, maintain equipment & utensils |
Perrigo Wisconsin, LLC | Food and Cosmetics | 11/29/2023 | System of process controls to prevent adulteration |