FDA 483 - Strata Skin Sciences, Inc. - June 16, 2015

The FDA inspection identified multiple violations at the facility. The firm failed to submit Medical Device Reports (MDRs) within 30 days for events reasonably suggesting a marketed device caused or contributed to a death or serious injury, or malfunctioned and would likely cause serious injury if recurring. Specifically, complaint CC-XMR-0495, alleging severe sunburn from XTRAC treatment, was not reported as the firm deemed it an isolated case of extreme sensitivity, not a serious injury. Complaint CC-XMR-0592, concerning an XTRAC LLG firing on its own, was also not reported despite physical damage found.

The firm's risk analysis procedure (SOP-0024) was inadequate, as 41 complaints (19 of which involved intermittent/not firing issues) related to the XTRAC laser family's Liquid Light Guide (LLG) component were not evaluated for post-market risk or as newly determined health risks.

Procedures for design change were not adequately established. Several Engineering Change Orders (ECOs 3233, 3437, 3524, 3761) for LLG touch control assemblies lacked justification for not requiring validation/verification, and the change process (WI-0001-A, AF-0006) did not require a regulatory assessment.

Corrective and preventive action procedures were insufficient. SOP-00