FDA EIR - Shearer's Foods, LLC - August 22, 2019

This FDA inspection of Shearer's Foods, LLC, located in Newport, AR, was conducted from August 19-22, 2019. The purpose was to assess the company's compliance with the regulatory framework of 21 CFR Part 117, which covers Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food (FSMA regulations). The facility manufactures various ready-to-eat snack foods, including tortilla, cheese puff, and cheese curl products.

While no formal FDA Form 483, Inspectional Observations, was issued, several concerns were noted and discussed with management. Key issues included water and air testing being six months past their due date, and a protein equipment swab retest result not being documented on production forms (though subsequent tests were negative). Additionally, actual numerical test values, such as pH results on tortilla line production sheets, were not being recorded; only "pass" or "fail" was indicated. The firm also preemptively refused photography during the inspection.

In response, the Quality Assurance/Food Safety Manager committed to initiating the overdue testing, investigating the lapse in retest result documentation, and reviewing regulatory requirements to ensure actual test values are recorded. These commitments were made internally, as the inspection did not result in formal regulatory findings.