FDA 483 - Accuon Labs, Inc - August 31, 2023

Accuon Labs, Inc. in Hauppauge, NY, was inspected from August 25-31, 2023, and received a Form 483. The inspection revealed significant deficiencies in laboratory controls, specifically concerning the construction, qualification, and environmental monitoring of clean rooms intended for microbial testing. These issues indicate a risk of contamination or mix-ups due to inadequate facility controls.