FDA Relaxes Onsite Observation Requirements Under FSMA Third-Party Certification Program

The U.S. Food and Drug Administration (FDA) is issuing a guidance to communicate its temporary policy regarding certain requirements under the FDA Food Safety Modernization Act (FSMA) Accredited Third-Party Certification Program for foreign food entities and their products.

The guidance addresses the current challenges with conducting onsite monitoring activities during the COVID-19 public health emergency by providing temporary flexibility so that recognized accreditation bodies (ABs) can maintain the accreditations of certification bodies (CBs), and so that already-issued certifications need not lapse, where certain safeguards are in place.

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