FDA 483 - Sterilmed, Inc. - May 22, 2024

An FDA inspection of Sterilmed, Inc., a reprocessor of single-use medical devices in Plymouth, MN, revealed significant deficiencies in its quality system. The firm failed to adequately control production processes, leading to reprocessed devices not conforming to specifications, including issues with biological foreign material and cracked distal tips. Additionally, the inspection found that corrective and preventive actions were not properly established, and risk analysis documentation was inadequate in identifying failure modes and causes.