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Quality / Medical Devices / Inspections and Audits

Medical Laser Manufacturer Draws Lengthy FDA Warning

Feb. 7, 2018
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Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection.

The warning came after the FDA was not satisfied with the firm’s December 2017 response to nonconformities listed in a Form 483.

It reveals numerous GMP violations regarding the firm’s procedures for handling complaints, and maintaining device history records, among other issues.

Out of the 12 violations in the warning, three relate to customer complaints. At least three of the complaint cases evaluated by the FDA during the inspection lacked the required root cause investigations or rationale for not initiating investigations, and the firm was unable to provide or locate another three of the reviewed complaints.

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