FDA WARNING_LETTER - LISA Laser Products OHG - October 04, 2012

An FDA inspection of Lisa Laser Products OHG in Katlenburg-Lindau, Germany, from October 1-4, 2012, revealed that their Sphinx Laser Systems, FlexGuard, and Revolix lasers are misbranded and violate quality system regulations. The firm failed to develop, maintain, and implement adequate Medical Device Reporting (MDR) procedures (21 CFR 803.17). Their revised procedure, "VAMPBeobachtungssystem (Medical Device Reporting), Rev 03V00," was inadequate, combining regulatory requirements inconsistently, lacking definitions for reportable events, and including outdated baseline reporting references.

Additionally, the firm exhibited significant quality system deficiencies (21 CFR Part 820), including: 1. Failure to establish and maintain adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)), with incomplete CAPA files and unverified corrective actions. 2. Failure to establish and maintain procedures for formal documented design reviews at appropriate stages, specifically lacking independent reviewers (21 CFR 820.30(e)). 3. Failure to establish and maintain procedures for validating device design, evidenced by distributing changed components (RigiFib) without validation (21 CFR 820.30(g)). 4. Failure to establish and maintain data describing requirements for purchased products and services, lacking adequate quality agreements with suppliers (