FDA 483 - BERLIN HEART GMBH - October 13, 2022

BERLIN HEART GMBH, a medical device manufacturer in Berlin, Germany, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, a lack of standardized medical device reporting processes, and deficiencies in design control procedures for both input and output. Additionally, the firm failed to ensure device history records aligned with master records and did not report a significant correction or removal to the FDA.