FDA 483 - WEBER MEDICAL GMBH - November 08, 2018

WEBER MEDICAL GMBH in Lauenfoerde, Germany, was inspected by the FDA from November 5-8, 2018, and received 15 observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, design control, non-conformance control, CAPA, supplier management, and medical device reporting. Additionally, numerous issues were identified with the labeling and safety features of their Class IIIb and Class IV laser products, indicating a broad lack of compliance with regulatory standards.