2020 FDA REFRIGERATION UPDATE

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Due to bacteria, food spoils quicker in your refrigerator than you might think. The FDA does not recommend storing many foods for more than 2 to 4 days – and that assumes your refrigerator is maintained at 4 degrees Celsius or cooler! Since many refrigerators don’t display temperature, upper portions of your refrigerator are possibly warmer and, therefore, unsafe. For home, the FDA recommends hanging an independent thermometer in the unit and checking it often. 

These short but safe time limits will help keep refrigerated food 40° F (4° C) from spoiling or becoming dangerous. Since product dates aren’t a guide for safe use of a product, consult this chart and follow these tips.

In the regulated space at work, the FDA has specific requirements around commissioning, qualification, and validation of refrigerators and other environmental chambers that control temperature and humidity. The FDA’s CGMPs govern the qualification of chambers that hold raw materials, analytical samples, process intermediates, and bulk/final product.  A documented validation, along with ongoing validation maintenance, is not optional – it is required for compliance.

Kymanox is a leading expert in these requirements, which include robust temperature mapping, calibration, procedural controls, and Good Documentation Practices. We have a dedicated team with the latest data logging equipment and industry-best templates for validation planning, risk assessments, Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs). We offer rapid, turnkey professional services for all chamber types including, but not limited to, refrigerators, freezers, ultra-low freezers, incubators, ovens, autoclaves, and warehouses.