MCELROY IMPORTS – FDA Warning Letter, Feb 9, 2021

From January 27, 2021, to February 9, 2021, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of McElroy Imports, following a previous inspection on June 11, 2019. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandates risk-based activities for importers to ensure food safety standards are met.

McElroy Imports was found non-compliant for Creamy Caramels with Sea Salt, (b)(4) Tea Bags, and (b)(4) from various foreign suppliers. The primary violation was the failure to develop, maintain, or follow an FSVP as required by 21 CFR 1.502(a).

Specifically for Creamy Caramels with Sea Salt, McElroy Imports failed to conduct a hazard analysis (21 CFR 1.504), evaluate foreign supplier performance (21 CFR 1.505), or perform adequate foreign supplier verification activities (21 CFR 1.506). Although some supplier documents were provided, the hazard analysis was not documented or reviewed, supplier performance evaluation was missing, and third-party audits were not adequately assessed for compliance with FDA regulations or promptly reviewed. No documents were provided for two other foreign suppliers.

Failure to address these violations may lead to refusal