Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 14.3% decrease from the number of companies cited in the previous year.
Of the 12 citations issued, the most common citation was 'You did not develop an FSVP'.
All of the companies cited were involved in either Food and Cosmetics or Devices sectors.
All of the companies cited should take voluntary actions to correct their managing operations.
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 |
---|---|---|---|
Amplion Clinical Communications, Inc. | Devices | 02/16/2023 | Individual Report of Malfunction |
Baraka Wholesale, Inc. | Food and Cosmetics | 06/16/2023 | Develop FSVP |
CryoSurgery, Inc. | Devices | 03/09/2023 | Lack of or inadequate final acceptance procedures |
CryoSurgery, Inc. | Devices | 03/09/2023 | Lack of or inadequate DHR procedures |
Eagle Food Service, LLC | Food and Cosmetics | 03/09/2023 | Develop FSVP |
Healing Innovations, Inc. | Devices | 08/01/2023 | Nonconforming product, Lack of or inadequate procedures |
La Hacienda Tortilleria, Inc. | Food and Cosmetics | 12/15/2023 | Personnel |
La Hacienda Tortilleria, Inc. | Food and Cosmetics | 12/15/2023 | Manufacturing, processing, packing, holding - Controls |
La Hacienda Tortilleria, Inc. | Food and Cosmetics | 12/15/2023 | Process preventive controls - Implement |
La Hacienda Tortilleria, Inc. | Food and Cosmetics | 12/15/2023 | Supply-chain program - Implement |
La Hacienda Tortilleria, Inc. | Food and Cosmetics | 06/21/2023 | Sanitary operations - Plant maintenance |
La Hacienda Tortilleria, Inc. | Food and Cosmetics | 06/21/2023 | Hazard analysis - Conducted |