FDA 483 - Contract Manufacturing NE LLC - June 06, 2022

Contract Manufacturing NE LLC in Bristol, CT, was cited for significant violations during an FDA inspection, primarily concerning allergen control and manufacturing practices. The firm failed to prevent allergen cross-contact, leading to undeclared tree nuts in products and a Class I recall. Additionally, the company lacked proper master manufacturing records for dietary supplements and operated under unsanitary conditions, including storing in-process food directly on the ground.