Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 100% increase over the number of companies cited in the previous year.
Of the 21 citations issued, the most common citations were 'You did not establish written procedures to ensure that you import foods only from approved foreign suppliers' and 'You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food'.
Most of the companies cited were involved in the Food and Cosmetics sector.
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 |
---|---|---|---|
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Evaluation of suppliers, contractors, etc., requirements |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Nonconforming product, Lack of or inadequate procedures |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Lack of or inadequate complaint procedures |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Supplier approval - document |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Approved supplier procedures - importer established |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Supplier verification - establish written procedures |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Record - English |
Brian Flowers | Drugs | 03/23/2023 | FD-1572, protocol compliance |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Quality control - quality, dietary supplement |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Reserve sample - collect, hold |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - holding |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - returned dietary supplement |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - product complaint |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Document review entity's hazard analysis |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Evaluation - performance, risk |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Verification activity before import, periodically |
Mtek Group, LLC | Food and Cosmetics | 09/27/2023 | Approved supplier procedures - importer established |
Premier Produce Services | Food and Cosmetics | 05/02/2023 | Supplier approval - document |
Premier Produce Services | Food and Cosmetics | 05/02/2023 | Onsite audit |
Renfro Foods, Inc. | Food and Cosmetics | 08/31/2023 | Process deviation |
Renfro Foods, Inc. | Food and Cosmetics | 08/31/2023 | Qualifications of individuals |