Nidek Inc – FDA Warning Letter, Apr 14, 2014

On August 8, 2014, the FDA issued a Warning Letter to Nidek, Inc. following an inspection from March 24 to April 14, 2014. The inspection revealed that Nidek's medical devices, including the Nidek EC-5000 Excimer Laser System and RT-5100 Refractor, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Key violations included: 1. **Failure to establish adequate CAPA procedures (21 CFR 820.100(a))**: CAPAs from a 2013 inspection (14-0005, 14-0009) were closed without implementing necessary corrective actions for repeated failures in recall reporting and personnel training. Nidek's proposed SOP revisions were not provided, and a comprehensive action plan for systemic deficiencies was lacking. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: 87% of reviewed customer service orders met the complaint definition but were not initiated as complaints. Critical information regarding patient impact for issues like YAG Laser System malfunctions and Keratome cutting problems was not obtained or documented.