Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 200% increase over the number of companies cited in the previous quarter.
Of the 10 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.
All of the companies cited were involved in the Devices sector.
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.
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 |
---|---|---|---|
GFS Chemicals, Inc. | Devices | 11/17/2023 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
IncludeHealth | Devices | 11/01/2023 | Management review - Lack of or inadequate procedures |
IncludeHealth | Devices | 11/01/2023 | Quality audits - Lack of or inadequate procedures |
IncludeHealth | Devices | 11/01/2023 | Design validation - software validation not performed |
IncludeHealth | Devices | 11/01/2023 | Lack of or inadequate procedures |
IncludeHealth | Devices | 11/01/2023 | Lack of or inadequate complaint procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Design control - no procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Purchasing controls, Lack of or inadequate procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Lack of or inadequate procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Investigation of device failures |