Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 25% decrease from the number of companies cited in the previous year.
Of the 28 citations issued, the most common citations were 'You did not identify a process preventive control for a hazard when one was needed' and 'Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use'.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Drugs sector.
Of the companies cited, eight should take voluntary actions to correct their managing operations (88.9%). Additionally, one company had to take regulatory and/or administrative actions (11.1%).
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 |
---|---|---|---|
Carbonator Rental Service, Inc. | Food and Cosmetics | 02/03/2023 | Sanitary operations - Plant sanitation |
Cho & So, Inc. | Food and Cosmetics | 07/21/2023 | Qualifications of individuals |
Cho & So, Inc. | Food and Cosmetics | 07/21/2023 | Cleaning and sanitizing substances - Safe and adequate |
Cho & So, Inc. | Food and Cosmetics | 07/21/2023 | Pest control |
Medical Products Laboratories, Inc. | Drugs | 07/13/2023 | Equipment Design, Size and Location |
Medical Products Laboratories, Inc. | Veterinary | 07/13/2023 | Equipment Design, Size and Location |
Moshe's Foods, LLC | Food and Cosmetics | 08/10/2023 | Personnel |
National Chemical Laboratories | Drugs | 05/26/2023 | Procedures not in writing, fully followed |
National Chemical Laboratories | Drugs | 05/26/2023 | Sanitation--buildings not clean, free of infestation |
National Chemical Laboratories | Drugs | 05/26/2023 | Cleaning / Sanitizing / Maintenance |
National Chemical Laboratories | Drugs | 05/26/2023 | Establish reliability of supplier's C of A |
National Chemical Laboratories | Drugs | 05/26/2023 | Absence of Written Procedures |
National Chemical Laboratories | Drugs | 05/26/2023 | Lack of written stability program |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | Sanitation of food-contact surfaces - Frequency |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | Plant operations - Precautions |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | Manufacturing, processing, packing, holding - Controls |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | Hazard analysis - Identification of hazard |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | Process preventive controls - Identify (Written) |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | Supply-chain program - Establish |
P&S Ravioli Company | Food and Cosmetics | 08/04/2023 | HACCP plan implementation |
Quaker Valley Foods | Food and Cosmetics | 08/24/2023 | Critical control points |
Quaker Valley Foods | Food and Cosmetics | 08/24/2023 | Critical limits |
Quaker Valley Foods | Food and Cosmetics | 08/24/2023 | Corrective action per predetermined plan |
Quaker Valley Foods | Food and Cosmetics | 08/24/2023 | Calibration - adequacy |
Ray's Snacks, Inc. | Food and Cosmetics | 02/10/2023 | Qualifications of individuals |
Ray's Snacks, Inc. | Food and Cosmetics | 02/10/2023 | Process preventive controls - Identify (Written) |
Sahara Enterprise, Inc. | Food and Cosmetics | 09/14/2023 | Hazard analysis written |
Sahara Enterprise, Inc. | Food and Cosmetics | 09/14/2023 | Verification activity assurance |