Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for design change have not been established.
- Procedures for corrective and preventive action have not been adequately established.
- A device master record has not been adequately maintained.
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 |
---|---|---|---|
Global Importing Group, Inc. | Food and Cosmetics | 01/08/2024 | Develop FSVP |
US Vascular, LLC | Devices | 03/06/2024 | Design changes - Lack of or Inadequate Procedures |
US Vascular, LLC | Devices | 03/06/2024 | Lack of or inadequate procedures |
US Vascular, LLC | Devices | 03/06/2024 | DMR - not or inadequately maintained |