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 7.7% decrease from the number of companies cited in the previous year.
Of the 35 citations issued, the most common citation was 'You did not take a reasonable measure or precaution related to personnel practices'.
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 Devices sector.
Of the companies cited, 12 should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (8.3%).
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 |
---|---|---|---|
Aarthun Enterprises, LLC | Food and Cosmetics | 09/08/2023 | Food safety plan |
Bergin Fruit Company, Inc. | Food and Cosmetics | 09/08/2023 | Personnel |
Bergin Fruit Company, Inc. | Food and Cosmetics | 09/08/2023 | Equipment and utensils - Design and maintenance |
Bergin Fruit Company, Inc. | Food and Cosmetics | 09/08/2023 | Allergen preventive controls - Implementation records |
Blackeye Beverage, LLC | Food and Cosmetics | 06/22/2023 | Thermal process crit factors-measurement adequate & accurate |
Blackeye Beverage, LLC | Food and Cosmetics | 06/22/2023 | Other systems - records; critical factors |
Blackeye Beverage, LLC | Food and Cosmetics | 06/22/2023 | Review of processing and production records |
Ermi Gebeya | Food and Cosmetics | 03/10/2023 | Develop FSVP |
Ermi Gebeya | Food and Cosmetics | 03/10/2023 | Identification - entry |
Gaoyoua Bakery, LLC | Food and Cosmetics | 10/25/2023 | Personnel |
Gaoyoua Bakery, LLC | Food and Cosmetics | 10/25/2023 | Sanitary facilities and controls |
Gaoyoua Bakery, LLC | Food and Cosmetics | 10/25/2023 | Modified requirement: Temperature control - Records |
IntriCon Corporation | Devices | 04/17/2023 | Contamination control, Lack of or inadequate procedures |
Lacteos Mi Chalatenango, Inc. | Food and Cosmetics | 09/27/2023 | Very small importer assurances, supplier |
Lacteos Mi Chalatenango, Inc. | Food and Cosmetics | 03/22/2023 | Develop FSVP |
Lovejoys Bloody Mary Mix | Food and Cosmetics | 01/23/2023 | Process filing |
Lovejoys Bloody Mary Mix | Food and Cosmetics | 01/23/2023 | Maintenance of processing and production records |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Training for supervisors |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Hygienic practices |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Food contact surface sanitary inspection and maintenance |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Buildings - drainage |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Written environmental monitoring plan |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Written sampling plan for spent irrigation water or sprouts |
MinnSprouts, LLC | Food and Cosmetics | 05/16/2023 | Analytical testing record |
RSP Prodo, LLC | Food and Cosmetics | 06/28/2023 | Personnel |
RSP Prodo, LLC | Food and Cosmetics | 06/28/2023 | Plant construction and design |
RSP Prodo, LLC | Food and Cosmetics | 06/28/2023 | Equipment and utensils - Design and maintenance |
RSP Prodo, LLC | Food and Cosmetics | 06/28/2023 | Manufacturing, processing, packing, holding - Controls |
RSP Prodo, LLC | Food and Cosmetics | 06/28/2023 | Storage and Distribution |
RSP Prodo, LLC | Food and Cosmetics | 06/28/2023 | Training records - General requirements |
Smiths Medical ASD, Inc. | Devices | 06/09/2023 | Process control procedures, Lack of or inadequate procedures |
Smiths Medical ASD, Inc. | Devices | 06/09/2023 | Nonconforming product, Lack of or inadequate procedures |
Westway Feed Products, LLC | Veterinary | 12/07/2023 | Three assays per year |
Westway Feed Products, LLC | Veterinary | 12/07/2023 | Assay results out of specification |
Westway Feed Products, LLC | Veterinary | 12/07/2023 | Prevention of unsafe contamination by equipment |