483
Aerolase Corp.FDA 483 - Aerolase Corp. - May 20, 2021
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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