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 quarter.
The citations in the county include:
- Cleaning compounds or sanitizing agents were not adequate for their intended use.
- Your master manufacturing record did not include all required information.
- Your batch production record did not include all required information.
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 |
---|---|---|---|
Innovative Flexpak | Food and Cosmetics | 08/22/2024 | Cleaning compounds - adequate, safe |
Innovative Flexpak | Food and Cosmetics | 08/22/2024 | Master manufacturing record - record requirements |
Innovative Flexpak | Food and Cosmetics | 08/22/2024 | Batch record - required information |
Innovative Flexpak | Food and Cosmetics | 08/22/2024 | Examination, testing; appropriate |