FDA WARNING_LETTER - ROYAL INTERNATIONAL TRADING LLC - March 17, 2020

On March 12 and 17, 2020, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Royal International Trading LLC, Montebello, CA. The inspection aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. safety standards.

The inspection revealed significant violations: the firm failed to develop, maintain, and follow FSVPs for specific imported products: (b)(4) Mushroom from (b)(4), (b)(4) Mushroom from (b)(4), and (b)(4) from (b)(4). This constitutes non-compliance with Section 805 of the FD&C Act and 21 CFR 1.502(a).

The firm's responses on March 24 and April 8, 2020, including HACCP audit records and a general HACCP Plan, were deemed inadequate. The FDA stated the firm did not provide a review of how these documents applied to their FSVP program, nor details or timeframes for developing and implementing FSVPs for specific products. The FDA emphasized the need to comply with 21 CFR 1.505 for foreign supplier evaluation and 21 CFR 1.506 for written procedures for approved suppliers.

Failure