FDA 483 - Automatic Rolls of North Carolina, LLC - February 13, 2025

The FDA inspected Automatic Rolls of North Carolina, LLC, a bakery in Clayton, NC, and issued a Form 483 with four observations. The inspection revealed failures in implementing sanitation preventive controls, inadequate review of sanitation and process preventive control records by a PCQI, and a refusal to provide requested records for copying. These issues indicate significant deficiencies in the firm's food safety management system.