FDA 483 - Boule Medical AB - May 11, 2018

Boule Medical AB, a medical device manufacturer in Spanga, Sweden, was cited for multiple quality system deficiencies during an FDA inspection from May 7-11, 2018. The firm lacked adequate procedures for corrective and preventive actions, complaint handling, supplier evaluation, device history records, and process controls. Additionally, written Medical Device Reporting (MDR) procedures were not developed, indicating systemic issues in their manufacturing and post-market surveillance processes for products like the Medonic M-series Hematology Analyzers.