FDA 483 - Hill Laboratories - July 27, 2022

Hill Laboratories, a medical device manufacturer in Frazer, PA, was cited with 11 observations during an FDA inspection from June 29 to July 27, 2022. The inspection revealed significant deficiencies across its quality system, including failures in MDR reporting, complaint handling, CAPA procedures, design control, device acceptance, equipment calibration, device master records, management reviews, and internal audits. These issues indicate a systemic breakdown in maintaining an effective quality system for medical device manufacturing.