FDA WARNING_LETTER - Sharplight Technologies - June 13, 2013

This FDA Warning Letter, dated November 25, 2013, was issued to Sharplight Technologies Ltd. in Rishon Le Zion, Israel, following an inspection from June 10-13, 2013. The firm manufactures powered surgical laser instruments, classified as devices, which were found to be adulterated due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820) and the Electronic Product Radiation Control provisions (21 CFR 1040).

Key QS violations included failures to establish and maintain adequate procedures for design verification (820.30(f)), design change control (820.30(i)), design validation (820.30(g)), formal design reviews (820.30(e)), and design and development plans (820.30(b)). Deficiencies were also noted in complaint handling (820.198(c), 820.198(b)), rework procedures (820.90(b)(2)), Device History Records (820.184), procedures for changes to specifications (820.70(b)), and overall document control (820.40). Additionally, the firm failed to permanently affix a certification label or tag as required by 21 CFR 1010.2.

While Sharplight Technologies Ltd. responded with corrective actions, the adequacy of several responses could not be determined without further documentation. The FDA requires a written response within fifteen business days detailing specific corrective and preventive actions, including a timetable for completion. Failure to address these violations could lead to federal agencies being advised and may prevent approval of premarket applications for Class III devices, indicating systemic quality management issues.