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 56.3% decrease from the number of companies inspected in the previous quarter, when 16 companies received 16 inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected worked in the Drugs sector.
There were five companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct the organization's management operations. Additionally, one company had to take regulatory and/or administrative actions.
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 | Result |
---|---|---|---|
ADMA Biologics, Inc. | Biologics | 09/20/2023 | No Action Indicated (NAI) |
Arcadlab, LLC | Devices | 09/01/2023 | Voluntary Action Indicated (VAI) |
Cosmetic Solutions, LLC | Drugs | 09/22/2023 | Official Action Indicated (OAI) |
Elevate Oral Care | Devices | 09/07/2023 | No Action Indicated (NAI) |
Hoffman's Commercial Group, Inc. | Food and Cosmetics | 07/24/2023 | No Action Indicated (NAI) |
Kenneth R. Beer, M.D. | Devices | 07/14/2023 | No Action Indicated (NAI) |
Samuel N. Lederman, M.D. | Drugs | 07/21/2023 | No Action Indicated (NAI) |