According to FSMA, how often are 'high risk' facilities inspected?

• A. Every year
• B. Every 3 years
• C. Every 5 years
• D. Every 10 years

Answer: (B)

FSMA uses a risk-based approach to determine how often FDA inspects facilities. Facilities classified as high risk are scheduled for inspections at least once every three years. This cadence prioritizes oversight where the potential public health impact is greatest, ensuring that high‑risk operations are reviewed more promptly.

An inspection every three years aligns with the intent to allocate resources to the facilities posing the most potential danger, rather than inspecting them annually or waiting many years between reviews. For non-high-risk facilities, the cadence is longer, such as about every five years, which is why the other timeframes don’t fit the high‑risk category. In practice, FDA may adjust timing based on factors like compliance history or new information, but the minimum for high-risk facilities is a three-year interval.