FDA 483 - Desarrollo E Investigacion Medica Aragonesa SL - December 19, 2019

BIMA S.L., a medical device manufacturer in Calatayud, Spain, was cited for significant deficiencies in its quality system during an FDA inspection. Key issues include failures in complaint handling and Medical Device Reporting (MDR), inadequate validation processes, and a lack of independent review in design and quality audits. The firm also had issues with incoming product acceptance procedures, indicating broad systemic problems.