FDA 483 - GF Health Products, Inc. - November 14, 2019

GF Health Products, Inc. in Warwick, RI, a drug manufacturer, was inspected by the FDA, resulting in five observations. The inspection revealed significant deficiencies in laboratory controls, including incomplete record-keeping for calculations and failure to follow established procedures for equipment calibration and document control. Additionally, the firm's batch production records lacked proper personnel identification for critical manufacturing steps, the facility showed poor maintenance with pest entry potential, and access to drug product labels was not adequately controlled.