By Maile Gradison Hermida, Guest Columnist
Records review will become a key component of the FDA’s FSMA inspections, so companies need to be sure that their records help, rather than hurt. Records must be thoughtfully prepared, complete, and accurate. Below are five facts about records under FSMA of which you may not be aware, emphasizing why companies need to include training on record creation as part of their FSMA preparations.
The FDA Can Review All Of The Records Related To Your Food Safety Plan — Without Cause
Currently, the FDA only has broad records access in emergency situations when it uses authority granted by the Bioterrorism Act. However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.
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