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 200% increase over the number of companies inspected in the previous quarter, when four companies received four inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics and Biologics sectors. The second most common type of company inspected worked in the Devices sector.
There were 10 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (83.3%). Two should take voluntary action to correct their management operations (16.7%).
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 |
---|---|---|---|
BioIVT, LLC | Biologics | 08/23/2023 | No Action Indicated (NAI) |
Blommer Chocolate Company | Food and Cosmetics | 09/22/2023 | No Action Indicated (NAI) |
Elite Spine, LLC | Biologics | 08/21/2023 | No Action Indicated (NAI) |
Hurter Food Distributors, Inc. | Food and Cosmetics | 08/16/2023 | No Action Indicated (NAI) |
JBS Souderton, Inc. | Veterinary | 09/07/2023 | Voluntary Action Indicated (VAI) |
Lucerne Dairy | Food and Cosmetics | 09/07/2023 | No Action Indicated (NAI) |
Main Line Fertility Clinic, P.C. | Biologics | 09/14/2023 | No Action Indicated (NAI) |
Martech Medical Products, Inc. | Devices | 09/01/2023 | No Action Indicated (NAI) |
Plurogen Therapeutics, LLC | Devices | 07/26/2023 | No Action Indicated (NAI) |
RadMD | Drugs | 08/04/2023 | No Action Indicated (NAI) |
Ritesource, Corp. | Food and Cosmetics | 07/28/2023 | Voluntary Action Indicated (VAI) |
Safe Guard Biologicals, Inc. | Biologics | 08/10/2023 | No Action Indicated (NAI) |