FDA 483 - Light Age, Inc. - September 29, 2023
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Light Age, Inc. in Somerset, NJ, was inspected from August 31 to September 29, 2023, revealing significant deficiencies across its quality system. The inspection found inadequate procedures for controlling nonconforming products, handling complaints, maintaining device master records, and managing calibration. Furthermore, the firm failed to establish proper corrective and preventive actions, conduct management reviews, control documents, and demonstrate design control for its Q-Clear device.
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ID · 17fb52c2-1956-4c8b-85e2-ebbd8e571c6b