FDA EIR - Permobil Inc - August 17, 2021

An FDA inspection of Permobil Inc., a manufacturer of Class II powered wheelchairs located in Lebanon, TN, was conducted from August 10-17, 2021. This abbreviated Quality System Inspection Technique (QSIT) Level I inspection, following Compliance Program 7382.845 for medical device manufacturers, specifically focused on Corrective and Preventive Action (CAPA) and Production and Process Controls. The primary violation identified was the inadequate establishment of procedures for corrective and preventive action, cited under 21 CFR 820.100(a). Specifically, Permobil failed to initiate a CAPA and conduct a health hazard evaluation for recurring adverse events concerning the standing function of their F5 Corpus VS powered wheelchair. Additionally, verbal concerns were raised regarding inconsistencies in documenting article numbers on nonconformance reports, CAPA investigations exceeding target due dates, and the Health Hazard Evaluation procedure lacking requirements to analyze warranty and call log data. A training record for a work instruction also lacked a necessary sign-off. In response, company management committed to correcting the observations. During the inspection, they initiated a CAPA to address the F5 Corpus VS standing function issue and planned to update ordering processes and user guidance to ensure proper medical clearance. Permobil also committed to retraining personnel on documentation practices and submitted a draft updated procedure for health hazard evaluations to incorporate warranty and call log data. The firm was reminded of its responsibility to comply with the Food, Drug, and Cosmetic Act.