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 a 50% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
- Your quality control personnel did not reject a component for which a specification was not met.
- You did not follow written procedures for the requirements for components of dietary supplements.
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 |
---|---|---|---|
CEMI International, Inc. | Food and Cosmetics | 11/03/2023 | Component - verify identity, dietary ingredient |
CEMI International, Inc. | Food and Cosmetics | 11/03/2023 | Specifications not met - reject, quality control |
CEMI International, Inc. | Food and Cosmetics | 11/03/2023 | Written procedures - components |
Hevener Sales, Inc. | Food and Cosmetics | 10/24/2023 | Develop FSVP |
Optimotion Implants, LLC | Devices | 10/20/2023 | Product rework adverse effects {see also 820.184} |