FDA Warning Letters for Temperature Non-compliance
As an FDA or USDA-regulated company, you can be audited for your compliance with FDA regulatory quality requirements. Audits of your biotech or food company by regulatory agencies may lead to an FDA warning letter that could have serious consequences for your business. A common finding is non-compliance in locations that require defined temperatures such as freezers, rooms, hot water, ovens, or product storage areas. The word "temperature" is listed in over 1600 warning letters issued by the FDA under Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Hazard Analysis and Critical Control Point (HACCP) guidelines.
These warning letters are public information and can be viewed by anyone.
Lower your risk of an FDA warning letter with the Tempurity™ System
You can use the Tempurity™ System from Networked Robotics to guard against out-of-compliance temperature observations. Because Tempurity System data is centralized, yet available to those that need it, you will always know what's missing before the audit.
The Tempurity System has been validated for FDA standards, including a comprehensive validation suite with specifications, test plan, validation report, and internal procedures for training and the development of our products. The Tempurity System is open to quality audit by you or by government regulatory bodies at our offices in the Chicago area. Click here for a list of the unique compliance features of Tempurity.
Quality has never been this easy. Put the network-based Tempurity System to work for you.
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Tempurity will collect data from ALL of your organization's monitored devices, wherever they are in the world. For different perspectives you may wish to read more from specific categories below: