DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 46.7% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Donor testing of HCT/P donors considered eligible was not negative or nonreactive for relevant communicable disease agents.
- Documentation of the donor-eligibility determination and the date of the donor-eligibility determination was not maintained.
- Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
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 .
Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).
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 |
Cookies-n-Milk, LLC | Food and Cosmetics | 10/19/2023 | Hazard analysis - Identification of hazard |
Cookies-n-Milk, LLC | Food and Cosmetics | 10/19/2023 | Supply-chain program - Implement |
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 |
Eminent Spine, LLC | Devices | 10/13/2023 | Info evaluated to determine if event was reportable |
Eminent Spine, LLC | Devices | 10/13/2023 | Design Validation - Risk analysis not performed/inadequate |
Eminent Spine, LLC | Devices | 10/13/2023 | Approval, inadequate purchasing data |
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 |
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 |