FDA 483 - LC Medical Concepts, Inc - February 25, 2020

Medical Concepts, Inc. in Rochester, NY, a medical device manufacturer, received a Form FDA 483 citing a repeat observation related to inadequate process validation. The firm failed to adequately validate the sterilization process for its UNI Negative Pressure Wound Therapy Kits. This included not performing required audits and failing to revalidate the process after a previous audit showed positive growth samples, indicating a significant potential risk to product sterility.