FDA WARNING_LETTER - Ida Foods Llc - July 02, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Ida Foods LLC from June 23, 2020, to July 2, 2020, following an initial inspection on August 28, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L.

Ida Foods LLC was found non-compliant for imported creamer stick from Lakeland Dairies Inc., Ireland; cream biscuit from Ceylon Biscuits Ltd., Sri Lanka; and bottled water from Societe Anonyme Des Eaux Minerales D "Evian, France. Significant violations include: 1. Failure to have a written hazard analysis or documented review and assessment of foreign supplier's hazard analysis (21 CFR 1.504(a), 1.504(d)). For creamer stick, the provided "HACCP Introduction" did not specify the product. No hazard analysis existed for cream biscuit or bottled water. 2. Failure to establish and follow adequate written procedures for approving foreign suppliers based on performance and risk, and documenting approval (21 CFR 1.505(a)(2), 1.505(b)). 3. Failure to determine and document required verification activities and frequencies to ensure hazard control (21 CFR 1.506(d