FDA 483 - SHUZY ROCK INC - February 14, 2022

SHUZY ROCK INC, a manufacturer of OTC drug products including hand sanitizers, was cited for severe deficiencies across its operations. The inspection revealed a complete lack of a quality control unit, inadequate production and process controls, and no testing of raw materials or finished products. Additionally, the firm lacked proper complaint handling, product traceability for recalls, equipment cleaning procedures, and had a deficient plumbing system.