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 quarter.
The citations in the county were 'Potential suppliers, contractors and consultants were not evaluated and selected based on their ability to meet specified requirements' and 'Procedures have not been adequately established to control product that does not conform to specified requirements'.
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 |
---|---|---|---|
Bound Tree Medical, LLC | Devices | 01/31/2024 | Evaluation and Selection, Suppliers, Contractors, etc. |
Bound Tree Medical, LLC | Devices | 01/31/2024 | Nonconforming product, Lack of or inadequate procedures |