FDA 483 - KEYSTONE INDUSTIRES - July 20, 2023

KEYSTONE INDUSTIRES, a packer/labeler in Swedesboro, NJ, was cited for significant deficiencies in its quality control unit, reserve sample management, and production record keeping. The inspection revealed issues with independent verification, unrepresentative reserve samples, and inadequate yield calculations that include undocumented reprocessed units. These findings indicate a lack of adherence to established procedures and proper documentation practices.