James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration.
- Failure to establish adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
- You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice and condition and cleanliness of food contact surfaces.
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 |
---|---|---|---|
Nelson Quality Shrimp Company, LLC | Food and Cosmetics | 05/30/2024 | Sanitation monitoring |
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 |