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 24.6% decrease from the number of companies inspected in the previous year, when 69 companies were inspected through 73 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 26 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (50%). 25 should take voluntary action to correct the organization's management operations (48.1%). Additionally, one company had to take regulatory and/or administrative actions (1.9%).
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 |
---|---|---|---|
Alk-abello, Inc. | Biologics | 03/09/2023 | Voluntary Action Indicated (VAI) |
Andrew Sapienza Bakery, Inc. | Food/Cosmetics | 01/24/2023 | Voluntary Action Indicated (VAI) |
Aroma Antico, Inc. | Food/Cosmetics | 04/20/2023 | No Action Indicated (NAI) |
Bagels By Bell, Ltd. | Food/Cosmetics | 12/05/2023 | Voluntary Action Indicated (VAI) |
Beyond Air, Inc. | Devices | 09/28/2023 | No Action Indicated (NAI) |
Blue Stone Import USA, Inc. | Food/Cosmetics | 03/27/2023 | Official Action Indicated (OAI) |
Carmel 1 | Food/Cosmetics | 08/22/2023 | Voluntary Action Indicated (VAI) |
Chief Import & Export, Corp. | Food/Cosmetics | 12/08/2023 | Voluntary Action Indicated (VAI) |
Cracker King Corporation | Food/Cosmetics | 11/01/2023 | No Action Indicated (NAI) |
Desi Fresh Foods, LLC | Food/Cosmetics | 08/03/2023 | No Action Indicated (NAI) |
Dial Industries, Inc. | Food/Cosmetics | 03/13/2023 | No Action Indicated (NAI) |
Fancy House, Inc. | Food/Cosmetics | 07/14/2023 | No Action Indicated (NAI) |
Food Ingredients Resources, Inc. | Food/Cosmetics | 01/31/2023 | No Action Indicated (NAI) |
Fougera Pharmaceuticals, Inc. | Veterinary | 11/17/2023 | Voluntary Action Indicated (VAI) |
Fresh Produce Import & Export, Inc. | Food/Cosmetics | 07/10/2023 | Voluntary Action Indicated (VAI) |
Gate Gourmet, Inc. | Food/Cosmetics | 04/17/2023 | Voluntary Action Indicated (VAI) |
Harbor Seafood, Inc. | Food/Cosmetics | 10/11/2023 | No Action Indicated (NAI) |
Huron Tool & Cutter Grinding Company | Devices | 12/05/2023 | Voluntary Action Indicated (VAI) |
Imacor, Inc. | Devices | 10/19/2023 | No Action Indicated (NAI) |
J2NY Manufacturing & Distribution, LLC | Food/Cosmetics | 04/05/2023 | Voluntary Action Indicated (VAI) |
JSO Associates, Inc. | Food/Cosmetics | 12/21/2023 | No Action Indicated (NAI) |
Jerry Shulman Produce Shipper, Inc. | Food/Cosmetics | 02/08/2023 | No Action Indicated (NAI) |
Joseph Seviroli, LLC | Food/Cosmetics | 04/04/2023 | No Action Indicated (NAI) |
Joseph Seviroli, LLC | Veterinary | 04/04/2023 | No Action Indicated (NAI) |
La Rustichella Truffles International USA, Corp. | Food/Cosmetics | 02/22/2023 | No Action Indicated (NAI) |
Life Plus Style Gourmet, LLC | Food/Cosmetics | 12/12/2023 | Voluntary Action Indicated (VAI) |
Lions Eye Bank For Long Island | Biologics | 08/03/2023 | Voluntary Action Indicated (VAI) |
My Dad's Gluten Free Products, Inc. | Food/Cosmetics | 03/14/2023 | No Action Indicated (NAI) |
NYU Langone Reproductive Specialists of New York | Biologics | 03/13/2023 | No Action Indicated (NAI) |
Nassau Candy NE Distribution Center | Food/Cosmetics | 12/13/2023 | No Action Indicated (NAI) |
Netech Corporation | Devices | 04/14/2023 | Voluntary Action Indicated (VAI) |
New York Blood Center Enterprises | Biologics | 10/27/2023 | Voluntary Action Indicated (VAI) |
New York Reproductive Wellness Medicine, P.C. | Biologics | 04/07/2023 | Voluntary Action Indicated (VAI) |
North Shore University Hospital Northwell Health | Biologics | 04/26/2023 | Voluntary Action Indicated (VAI) |
Northern Food I/E, Inc. | Food/Cosmetics | 10/31/2023 | Voluntary Action Indicated (VAI) |
Oximeter Plus, Inc. | Devices | 07/21/2023 | Voluntary Action Indicated (VAI) |
P & L Development, LLC | Tobacco | 08/16/2023 | No Action Indicated (NAI) |
Precipart, Corp. | Devices | 12/20/2023 | No Action Indicated (NAI) |
Quesos La Ricura, Ltd. | Food/Cosmetics | 08/23/2023 | Voluntary Action Indicated (VAI) |
Richard A. Shlofmitz, M.D. | Devices | 12/07/2023 | No Action Indicated (NAI) |
Robert Alfonso Duarte, M.D. | Drugs | 05/19/2023 | No Action Indicated (NAI) |
SLR Food Distribution, Inc. | Food/Cosmetics | 11/15/2023 | No Action Indicated (NAI) |
Sciarra Laboratories, Inc. | Drugs | 08/07/2023 | Voluntary Action Indicated (VAI) |
Supreme Screw Products | Devices | 09/06/2023 | No Action Indicated (NAI) |
The Hamptons Honey Company, LLC | Food/Cosmetics | 05/19/2023 | No Action Indicated (NAI) |
Time-Cap Laboratories, Inc. | Food/Cosmetics | 10/10/2023 | No Action Indicated (NAI) |
Toyo International Trading, Inc. | Food/Cosmetics | 11/01/2023 | No Action Indicated (NAI) |
US Merchandise, LLC | Devices | 06/28/2023 | Voluntary Action Indicated (VAI) |
Vasomedical, Inc. | Devices | 01/09/2023 | Voluntary Action Indicated (VAI) |
William H. Kopke Jr., Inc. | Food/Cosmetics | 08/14/2023 | No Action Indicated (NAI) |
Wm. E. Martin & Sons Company, Inc. | Food/Cosmetics | 09/15/2023 | Voluntary Action Indicated (VAI) |
dnata US Inflight Catering, LLC | Food/Cosmetics | 02/02/2023 | Voluntary Action Indicated (VAI) |
iTreat, Inc. | Food/Cosmetics | 10/31/2023 | Voluntary Action Indicated (VAI) |
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