DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- Your quality control personnel did not approve or reject specifications, written procedures and tests that may affect the identity, purity, strength, or composition of a dietary supplement.
- Procedures for changes to a specification have not been adequately established.
- The evaluation of potential suppliers was not documented.
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.
According to its website, 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.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Cardio Flow, Inc. | Devices | 05/17/2024 | Documented evaluation |
Cardio Flow, Inc. | Devices | 05/17/2024 | Lack of or inadequate complaint procedures |
Rich Products Corporation | Food and Cosmetics | 06/03/2024 | Pest control |
Virtex | Devices | 04/19/2024 | Production and Process Change Procedures, lack of or Inad. |
WellnessOne, Inc. | Food and Cosmetics | 08/01/2024 | Quality control - processes, specifications, written procedures |