FDA WARNING_LETTER - Selected Food & Beverage, Inc. - May 25, 2021

On September 7, 2021, the FDA issued a Warning Letter to Selected Food & Beverage, Inc. following Foreign Supplier Verification Program (FSVP) inspections on May 6 and May 25, 2021, and a prior inspection on September 20, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L.

The FDA found significant violations, noting the company failed to develop, maintain, and follow an FSVP for imported foods, including Olive Oil, Artichokes Quartered in Brine, and Tomato Sauce, as required by 21 CFR 1.502(a). This non-compliance was observed despite a Form FDA 483a FSVP Observations being issued on May 25, 2021, to which no response was received.

Additionally, the facility at 7207B Wynnwood Ln., Houston, TX 77008-6031, was found to be unregistered, violating the food facility registration requirement under Section 415 of the Act and 21 CFR Part 1, Subpart H. Failure to register is a prohibited act under Section 301(dd).

The FDA requires the company to register its facility within 30 working days and respond in writing within 15