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 month.
Of the five citations issued, the most common citation was 'You did not establish label specifications'.
Both 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 |
|---|---|---|---|
| AMF Pharma, LLC | Food and Cosmetics | 01/16/2024 | Specifications - component identity |
| AMF Pharma, LLC | Food and Cosmetics | 01/16/2024 | Specifications-component purity, strength, composition |
| AMF Pharma, LLC | Food and Cosmetics | 01/16/2024 | Specifications - labels, packaging |
| AMF Pharma, LLC | Food and Cosmetics | 01/16/2024 | Specifications - identity, purity, strength, composition |
| Arcman Pharma Corporation | Food and Cosmetics | 01/16/2024 | Specifications - labels, packaging |
Alerts Sign-up