FDA 483 - Avery Biomedical Devices, Inc. - July 16, 2019

Avery Biomedical Devices, Inc., a medical device manufacturer in Commack, NY, was inspected by the FDA from July 11-16, 2019. The inspection revealed a significant issue regarding equipment calibration documentation. Specifically, a generator used for in-house calibration of other devices was not calibrated and lacked traceability to the National Institute of Standards and Technology (NIST).