Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not develop an FSVP.
- You did not have a written hazard analysis.
- You did not establish and maintain procedures for testing and screening of HCT/P donors.
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 |
|---|---|---|---|
| Cade Medical, Inc. | Biologics | 08/30/2024 | Records incomplete |
| Lin, James P, Inc., M.D. | Biologics | 08/22/2024 | Testing, screening, donor eligibility procedures |
| Lin, James P, Inc., M.D. | Biologics | 08/22/2024 | Donor screening standards |
| Lin, James P, Inc., M.D. | Biologics | 08/22/2024 | Risk factors, clinical evidence |
| Maihan Distributors, Inc. | Food and Cosmetics | 08/21/2024 | Develop FSVP |
| Maihan Distributors, Inc. | Food and Cosmetics | 08/21/2024 | Hazard analysis written |
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