Stay in FDA Compliance and Clear of Warning Letters for Product Temperature Monitoring

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The importance of monitoring and recording temperatures correctly with Traceable® data loggers equipped with TraceableLIVE® cloud-based service

If your workplace is inspected by the U.S. Department of Food and Drug Administration (FDA), it may be one of the most stressful times for you, especially if you’ve received an FDA Warning Letter. Did you know that over the course of one year, the FDA sends hundreds of warning letters to companies not meeting their FDA compliance for many reasons? Some of these warning letters address lack of proper temperature and/or humidity monitoring for products that require specific temperatures in cold storage. These Warning Letters may address not recording temperatures of storage conditions for temperature-sensitive items to using a thermometer probe to quickly check a product’s temperature. Adding Traceable data loggers equipped with TraceableLIVE can help you to stay in FDA compliance and clear of Warning Letters for temperature monitoring of your heat-sensitive items.

The responsibility of the FDA is to protect public health

The FDA is responsible for protecting the public’s health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and maintaining the safety of our nation’s human and animal food supplies, cosmetics, and products that emit radiation.

To do this, the FDA provides documents with the regulations for manufacturers to follow and then enforces the regulations. Then the FDA will inspect facilities to ensure the manufacturers comply with these regulations. Failure to comply is likely to result in a Warning Letter. This is a simplified explanation, but the entire regulatory process is laborious and ongoing.

Why does the FDA issue a Warning Letter to a manufacturer?

When the FDA finds that a manufacturer has significantly violated FDA regulations, the FDA sends a Warning Letter to the manufacturer. The Warning Letter identifies the violation, such as with the companies mentioned above that had improper temperature monitoring. The letter also states that the company must correct the problem and provides directions to the FDA about how it will correct the violation(s). The FDA then follows up to check if adequate corrections have been made. If adequate corrections have not been met, it may result in a Federal lawsuit.

How TraceableLIVE can help you stay in compliance with FDA temperature monitoring regulations

When dealing with temperature monitoring regulations, it’s so easy to stay in compliance with FDA regulations by simply adding a Traceable data logger equipped eith TraceableLIVE cloud-based service. This allows you to easily monitor temperature, humidity, and other conditions 24/7 from wherever you are via your Internet-connected devices. You can also record the data for your temperature-sensitive items.

Because TraceableLIVE can record and store the data for future use, it meets FDA Code of Federal Regulations (CFR) Title 21. And TraceableLIVE-compatible devices are calibrated to NIST standards to help you meet quality and regulatory recommendations.

You can also securely connect via a smartphone, tablet, or PC to view current conditions anywhere and access data logging history, reports, and more. Set up is simple and easy. TraceableLIVE features unlimited scalability and segmentability.

In addition to cloud-based data storage, TraceableLIVE will send notifications to your personal devices if temperatures of your items go out of range. This can help you prevent loss of items, and the alerts can help to keep you in compliance and prevent FDA Warning Letters.

Learn more about how TraceableLIVE works to keep you in business and in compliance.

View TraceableLIVE information

Try out the live demo of TraceableLIVE

Take TraceableLIVE for a test drive and see how it can help you secure temperature-sensitive items.

Try the demo now


1-, About Warning Letters and Close-Out Letters, Accessed, September 20, 2023.
2-, What We Do, Accessed, September 20, 2023.View TraceableLIVE information

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