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 26.7% decrease from the number of companies inspected in the previous year, when 30 companies were inspected through 30 inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Devices sector.
There were 19 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (86.4%). Three should take voluntary action to correct the organization's management operations (13.6%).
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 |
---|---|---|---|
Alliance Precision Plastics Corporation | Devices | 12/20/2023 | No Action Indicated (NAI) |
BioTel Research, LLC | Drugs | 04/26/2023 | No Action Indicated (NAI) |
DJ Acquisition FTT, LLC | Devices | 10/12/2023 | Voluntary Action Indicated (VAI) |
Exxelia Micropen | Devices | 11/14/2023 | No Action Indicated (NAI) |
First Source, Inc. | Devices | 09/19/2023 | Voluntary Action Indicated (VAI) |
Fuego Coffee Roasters, LLC | Food/Cosmetics | 08/09/2023 | No Action Indicated (NAI) |
LiDestri Foods, Inc. | Food/Cosmetics | 11/30/2023 | No Action Indicated (NAI) |
McKesson Medical-Surgical | Food/Cosmetics | 07/25/2023 | No Action Indicated (NAI) |
Medline Industries, LP | Food/Cosmetics | 07/13/2023 | No Action Indicated (NAI) |
Musculoskeletal Transplant Foundation | Biologics | 05/24/2023 | No Action Indicated (NAI) |
Napoli Specialty Concepts, Inc. | Food/Cosmetics | 08/08/2023 | No Action Indicated (NAI) |
Nortera Foods USA | Food/Cosmetics | 09/25/2023 | No Action Indicated (NAI) |
Paneffort, LLC | Devices | 12/05/2023 | No Action Indicated (NAI) |
Pennant Ingredients, Inc. | Food/Cosmetics | 06/01/2023 | No Action Indicated (NAI) |
Pennant Ingredients, Inc. | Veterinary | 06/01/2023 | No Action Indicated (NAI) |
Rochester Regional Health Fertility Care | Biologics | 04/19/2023 | No Action Indicated (NAI) |
Roechling Medical Rochester, L. P. | Devices | 10/27/2023 | No Action Indicated (NAI) |
Sight Society of NENY Lions Eye Bank of Rochester, Inc. | Biologics | 05/03/2023 | No Action Indicated (NAI) |
Ti-Ba Enterprises, Inc. | Devices | 02/10/2023 | No Action Indicated (NAI) |
Turbett Surgical, Inc. | Devices | 06/26/2023 | Voluntary Action Indicated (VAI) |
University of Rochester - Strong Memorial Hospital | Biologics | 09/13/2023 | No Action Indicated (NAI) |
Wegmans Food Markets, Inc. | Food/Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
Wegmans Food Markets, Inc. | Food/Cosmetics | 01/30/2023 | No Action Indicated (NAI) |