Laser Engineering, Inc. – FDA Warning Letter, Apr 4, 2014

On March 26-28 and April 1-4, 2014, an FDA inspection of Laser Engineering, Inc., a manufacturer of surgical lasers, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), Electronic Product Radiation Control (21 USC 360oo(a)), and Medical Device Reporting (21 USC 360i, 21 CFR 803).

Key violations include: - **Quality System Deficiencies:** Failure to document approval signatures for quality system procedures (21 CFR 820.40(a)), inadequate complaint evaluation and investigation (21 CFR 820.198(b)), failure to implement and record corrective and preventive actions (CAPA) (21 CFR 820.100(a)(5)), lack of design control documentation for the Dual Switch (DS) optical switch (21 CFR 820.30(j)), incomplete device master records (DMRs) (21 CFR 820.181), failure to establish and maintain records of acceptable suppliers (21 CFR 820.50(a)(3)), uncalibrated equipment and lack of remedial action (21 CFR 820.72(b)), use of obsolete documents (21 CFR 820.40(a)), release of