FDA 483 - Avery Biomedical Devices, Inc. - April 17, 2017

During an inspection from April 13-17, 2017, the FDA observed one significant issue at Avery Biomedical Devices, Inc. in Commack, NY. The firm, a medical device manufacturer, failed to adequately establish procedures for controlling environmental conditions in its clean room. This indicates a lack of proper monitoring for temperature and humidity, which is critical for product quality and safety.