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

During an inspection conducted from September 17-19, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Multi-Med, Inc., a medical device manufacturer located in Keene, NH. The inspection revealed significant concerns regarding the firm's adherence to quality system requirements, indicating potential non-compliance with regulatory frameworks governing medical device manufacturing.

Key observations included inadequate documentation of labels and labeling for finished products. Specifically, sterile devices such as Extension Sets and Tubing with Enteral Adapters & Connectors lacked required expiration dates on their labels. Furthermore, the firm failed to adequately document equipment calibrations. In-house calibration records for critical testing tools, including various gauges and calipers, did not identify the standard equipment used or demonstrate traceability to NIST. A third major finding involved the insufficient maintenance of device history records; the contract sterilizer's processing records were missing lot numbers for the sterilization indicators utilized.

The issuance of this FDA-483 necessitates that Multi-Med, Inc. promptly address these observations by conducting thorough internal audits and implementing comprehensive corrective and preventive actions to ensure full compliance and uphold product quality and patient safety.