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 57.9% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not ensure that your electronic mail address were provided electronically when filing entry with the U.S. Customs and Border Protection.
- You did not document that the foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and that the food is within the scope of FDA's official recognition or equivalency determination before importing a food from a foreign supplier and on an annual basis.
- Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to 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 .
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 |
---|---|---|---|
Buda Juice, LLC | Food and Cosmetics | 11/14/2023 | HACCP plan - monitoring procedures - none listed |
Buda Juice, LLC | Food and Cosmetics | 11/14/2023 | HACCP plan - corrective action plan not included |
Divine Design Manufacturing | Food and Cosmetics | 11/21/2023 | Specifications - component identity |
Divine Design Manufacturing | Food and Cosmetics | 11/21/2023 | Specifications - identity, purity, strength, composition |
Divine Design Manufacturing | Food and Cosmetics | 11/21/2023 | Component - verify identity, dietary ingredient |
Divine Design Manufacturing | Food and Cosmetics | 11/21/2023 | Documentation - qualify supplier |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Donor testing not negative for CD agents |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Documentation--determination, by whom, date |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Risk factors, clinical evidence |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Eligibility not required--warning labels |
La Fabrica, LLC | Food and Cosmetics | 11/06/2023 | Manufacturing, processing, packing, holding - Controls |
Marriott International, Inc. | Food and Cosmetics | 11/13/2023 | Identification - entry |
Marriott International, Inc. | Food and Cosmetics | 11/13/2023 | Regulatory oversight |
Mary Kay, Inc. | Drugs | 10/27/2023 | Cleaning SOPs/equipment protection |
Parvez Mantry | Drugs | 11/14/2023 | FD-1572, protocol compliance |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Document change records, maintained. |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Acceptable supplier records, inadequate records |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Lack of or inadequate procedures |