White Trading Corporation – FDA Warning Letter, Jul 31, 2020

On December 15, 2020, the FDA issued a Warning Letter to White Trading Corporation following a remote Foreign Supplier Verification Programs (FSVP) inspection from July 21-31, 2020, and a previous inspection on May 1, 2018. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The FDA found that White Trading Corporation was not in compliance, specifically lacking an FSVP for imported food products, including but not limited to (b)(4) Cheese from (b)(4). This constitutes a significant violation of Section 805 of the FD&C Act and 21 CFR 1.502(a). Form FDA 483a, FSVP Observations, was issued after both inspections.

Despite an August 21, 2020, response from White Trading Corporation indicating progress on FSVP development and documentation, no further documentation was provided to the FDA following a September 17, 2020, follow-up.

The FDA requires prompt corrective action. Failure to comply may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, including detention without physical examination (DW