Sharp Increase in Importer FSVP Violations Found in FDA's FY18 Inspections

The Food and Drug Administration found some 300 violations of Foreign Supplier Verification Program requirements during inspections in fiscal year 2018, making it the most frequently cited food-related issue for the fiscal year, according to FY18 inspection observations posted to the agency website. FDA cited at least 278 importers for failure to develop an FSVP, with another 11 also cited for a similar reason with a different citation code.

A handful of importers were also cited for more specific FSVP violations. A total of 10 citations were issued for failure to maintain adequate records, including missing records and failure to sign and date them or translate them to English. Another two inspections found a requested FSVP record was not made available to the inspector.

FDA had cited about 100 importers for FSVP violations in inspections conducted in FY17, according to a blog post from Registrar Corp. The agency has up to now held off on enforcement action for FSVP violations found in its inspections, though some suspect the agency could begin issuing warning letters and import alerts in fiscal year 2019 as it begins to revisit the facilities it previously cited (see 1812130046).

“FSVP’s prominence on this year’s list of violations suggests that FDA is regularly inspecting importers for compliance,” Registrar Corp said. “Importers should be prepared for FDA to examine their FSVP records and verify that they are properly monitoring their suppliers. Non-compliance with FSVP regulations may result in civil penalties.”

Meanwhile, while FDA’s list had no category for violations of preventive controls requirements for human food, about 400 violations were listed that relate to those new regulatory requirements, Registrar Corp said. “These include issues such as not having a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plan, not identifying a hazard that requires a preventive control in a HARPC Plan, not utilizing a Preventive Controls Qualified Individual (PCQI) to prepare or oversee a HARPC Plan, not implementing adequate procedures for monitoring sanitation or allergen controls, and more,” it said.

“The deadlines for most facilities to comply with Preventive Controls requirements have passed, and these violations are evidence that FDA is actively inspecting facilities for compliance with the rules,” Registrar Corp said. “Facilities should familiarize themselves with Preventive Controls regulations to ensure they are properly accounting for all HARPC requirements and any differences from other food safety systems they may be using to draft their HARPC plans.”