Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county were 'The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration' and 'Failure to establish adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments'.
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 |
---|---|---|---|
Savannah Health Services, LLC | Biologics | 06/12/2024 | Schedules and procedures for equipment & calibration |
Savannah Health Services, LLC | Biologics | 06/12/2024 | Provisions to monitor lab test procedures & instruments |