483
Accuon Labs, IncFDA 483 - Accuon Labs, Inc - August 31, 2023
Record Details
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.
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ID · f83a7cc3-ab9e-40f6-970f-f1e86dab9956
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