FDA 483 - Multi-Med, Inc. - September 19, 2024

An FDA inspection of Multi-Med, Inc. in Keene, NH, a medical device manufacturer, revealed three significant observations. The firm was cited for inadequate documentation of labels and labeling, including expiration dates for sterile devices, and insufficient records for in-house equipment calibrations. Additionally, deficiencies were noted in the maintenance of device history records, specifically regarding sterilization process documentation.