The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Medical Laser Manufacturer Draws Lengthy FDA Warning

Feb. 2, 2018

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.

Light Age had failed to adequately follow its complaint investigation procedure as it was lacking documentation on complaint trending and metrics reviews being performed. It was also unable to demonstrate during the FDA’s visit that it had reviewed or investigated three complaints involving possible injuries — a Keloid scarring, a burn, and a rash.

In its response to these issues, the firm failed to ease the FDA’s concerns due to a lack of written evidence of having conducted a retrospective review of all complaints and of having revised its complaint handling system. It also did not provide explanation for the missing complaints.

The firm’s device master record for its EpiCare Zenith device and several of its DHRs were found to be incomplete. The DMR lacked references to packaging, labeling, and installation specifications, among others, and DHRs for some of the identified distributed devices were missing critical manufacturing information, such as a justification for a previously set pulse rate.

The investigator also observed the lack of calibration records for products used to manufacturer EpiCare Zenith devices during 2015, 2015, and 2016, as well as of design change validations. For example, the firm implemented an engineering change on its EpiCare portfolio in 2011 for safety reasons, but it failed to document whether the design change was verified or validated.

The response to these nonconformities was inadequate in that completed DHRs were not provided for the identified examples, and it did not indicate whether the firm has “retrospectively reviewed all DHRs for devices which remain on the market to ensure they are complete and that nonconforming results have been adequately investigated,” the agency said. 

Light Age’s inadequate procedures for controlling nonconforming products, implementing CAPA actions, as well as conducting timely management reviews and internal quality audits were also found to be significant GMP violations.

The FDA found several CAPAs since January 2015 had been opened and then cancelled without rationales or actions taken, and nonconforming products that had been shipped without documented investigations or risk assessments. According to the firm’s quality manager, nonconformities had not been documented since August 2016. Updated SOPs and associated personnel training records should have been included in the firm’s response to these violations.

Lastly, the firm’s processes, or lack thereof, for adverse event reporting were found to be in violation of the FDA’s Medical Device Reporting requirements. Its MDR procedures were deficient as they did not establish internal systems or describe requirements to ensure adequate recordkeeping and complete event investigations, as well as timely submissions to the FDA.

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