FDA 483 - Liveyon - May 23, 2019

An FDA inspection of Liveyon LLC, a biological drug own label distributor located in Yorba Linda, CA, was conducted from May 13 to May 23, 2019. The inspection resulted in a significant observation regarding the company's procedures for handling complaints related to drug products, indicating a potential deviation from regulatory expectations for quality systems. Specifically, the company's "Handling Adverse Events/Product Recall" procedure (QA-002) was found to be deficient. It failed to specify crucial timeframes for logging and routing received complaints, determining whether an investigation is needed, and concluding the complaint or investigation process. Furthermore, the procedure did not accurately reflect current operational practices, particularly concerning the designated personnel (the Chief Compliance Officer) responsible for receiving, logging, and routing complaints. This observation highlights a need for Liveyon LLC to revise and implement robust complaint handling procedures that include clear timelines and accurately reflect their operational workflow to ensure compliance with quality system regulations for drug products. The company is expected to address these observations to uphold product quality and patient safety.