FDA 483 - kdc/one Chatsworth, Inc. - March 24, 2023

kdc/one Chatsworth, Inc. in Chatsworth, CA, a manufacturer of cosmetics and OTC drug products, was inspected by the FDA from March 20-24, 2023. The inspection revealed significant deficiencies across multiple areas, including inadequate cleaning and sanitization of equipment, improper calibration of instruments, failures in quality control unit oversight, and poor documentation practices. Additionally, the firm was cited for late annual product reviews, insufficient GMP training, lack of proper warehousing procedures leading to temperature excursions, and inadequate handling of customer complaints.