Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- Equipment used for measuring was not capable of producing valid results.
- The procedures and schedules for the calibration of equipment used for measuring were not established and maintained.
- Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
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 |
---|---|---|---|
Supreme Orthopedic Systems, Inc. | Biologics | 08/23/2024 | Capable of valid results |
Supreme Orthopedic Systems, Inc. | Biologics | 08/23/2024 | Calibration procedures and schedules (general) |
Supreme Orthopedic Systems, Inc. | Biologics | 08/23/2024 | Periodic review of temperatures |