James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for corrective and preventive action have not been established.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
- There is no quality control unit.
Both 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 |
---|---|---|---|
Fidelitone Order Fulfillment, LLC | Drugs | 10/26/2023 | Lack of quality control unit |
Max Mobility, LLC | Devices | 12/07/2023 | Lack of or inadequate procedures |
Max Mobility, LLC | Devices | 12/07/2023 | Lack of or inadequate complaint procedures |