Yes, a facility inspection is often required for FDA certification in the United States, especially for certain types of devices. Here’s when a facility inspection might be required:
Facility inspections are an integral part of the FDA certification process, especially for high-risk devices (Class III) or when concerns about quality or safety arise. Inspections are conducted to ensure that manufacturers comply with FDA regulations, including Good Manufacturing Practices (GMP) or Quality System Regulations (QSR). However, for low-risk devices, such as those classified under Class I, facility inspections may not always be necessary, though they can still occur if deemed appropriate by the FDA.
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