While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future required timeframes. The report comes this week from the U.S. Department of Health and Human Services Office of Inspector General, which used FDA’s inspection data and information about FDA’s advisory and enforcement actions to provide its analysis and recommendations.
Notable findings include:
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Specified FSMA timeframes. For the initial cycle, FSMA requires FDA to inspect all high-risk facilities within five years and all non-high risk facilities with seven years. While FDA is on track to meet these deadlines, FSMA thereafter requires a quicker timeframe – three years for high-risk facilities and five years for non-high risk facilities. The report found that the shorter timeframe poses a challenge for non-high risk facilities in particular.
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Inaccurate information. The report found that more than one quarter of high-risk and non-high-risk facilities that FDA counted toward meeting inspection mandates were attempted inspections but were never actually completed due to the facility being out of business or not in operation. FDA inspections are generally unannounced.
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Correcting significant inspection violations. According to the report, FDA uncovered significant inspection violations in 1-2% of inspected facilities or 1,245 facilities. FDA most commonly relied on advisory actions such as warning letters, u
ntitled non-public letters, or regulatory meetings to address these issues, as shown in the pie chart to the right. The report noted that advisory actions do not necessarily ensure that the identified issues are corrected and commented that FDA declined to regularly use the new administrative tools authorized under FSMA, such as administratively detaining unsafe food, mandating recalls of certain foods, and suspending facility registrations and prohibiting the facility from distributing food.
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Timeliness of follow-up. The report further noted that FDA may not always timely follow-up with facilities even when a significant inspection issue was identified. According to the data, about half the time, FDA either did not follow-up within one year (31%) or did not follow up at all (17%).
FDA responded to the report by noting that it concurred with the Inspector General’s recommendations and would implement certain corrective actions to address the identified issues.
