FDA 483 - Mettler Electronics Corp - September 14, 2023

An FDA inspection of Mettler Electronics Corp in Anaheim, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish records for acceptable suppliers, ensure proper re-evaluation of critical suppliers, and document labeling changes for their medical devices. Additionally, personnel training for critical document change procedures was not documented, indicating a need for improved procedural adherence and record-keeping.