FDA 483 - Country Life, LLC - March 01, 2019

An FDA inspection of Country Life LLC, a manufacturer and own label distributor in Hauppauge, NY, revealed significant deficiencies across multiple areas. Observations included improper storage of raw materials leading to potential contamination, inadequate documentation for packaging equipment validation, and a lack of defined acceptance criteria for dietary ingredient specifications. Additionally, the firm failed to properly document the closure of serious adverse event complaints.