FDA 483 - Handicare Accessibility, Ltd. - February 07, 2019

Handicare Accessibility, Ltd., a foreign medical device manufacturer of powered stairway chair lifts, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for complaint handling and corrective and preventive actions, leading to hundreds of uninvestigated complaints and retrospective CAPA documentation. Additionally, the company did not conduct scheduled internal quality audits and submitted Medical Device Reports beyond the required 30-day timeframe.