Covetrus North America LLC. – FDA EIR, Aug 29, 2022

An FDA surveillance inspection was conducted at Covetrus North America LLC, located in Aurora, CO, on August 29, 2022. The facility functions as an ambient and frozen warehouse for the distribution of unexposed packaged veterinarian supplies and animal food products intended for pets. The comprehensive inspection was carried out in accordance with CPGM 7371.000, which outlines Comprehensive Animal Food Inspections, and specifically covered Subparts A, B, and F of 21 CFR 507. Key areas reviewed included the firm's training records, purchase and receipt documentation, and pest control procedures. Furthermore, the inspection addressed compliance with Bovine Spongiform Encephalopathy (BSE) regulations and current Good Manufacturing Practices (CGMP) under Part 507. This visit marked the initial FDA inspection for Covetrus North America LLC. Importantly, the inspection concluded with no significant violations or issues identified, as evidenced by the absence of an FDA Form 483, Inspectional Observations. Therefore, no specific corrective or required regulatory actions were mandated for the firm following this assessment, indicating compliance with the applicable regulatory frameworks governing animal food warehousing and distribution.