483
Aerolase Corp.Aerolase Corp. – FDA 483, May 20, 2021
Record Details
An FDA inspection of Aerolase Corp. in Tarrytown, NY, from May 11-20, 2021, revealed significant deficiencies in quality system compliance. Observations included the lack of proper certification labels on finished laser devices, inadequate maintenance of device history records, and insufficient corrective and preventive action procedures, particularly regarding effectiveness checks.
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ID · 55646690-8312-4fa0-b6cd-205b3408a0e6
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