Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county were 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established' and 'Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual and clearly identified'.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLC | Devices | 07/03/2024 | Lack of or inadequate complaint procedures |
| NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLC | Devices | 07/03/2024 | Evaluation, timeliness, identification |
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