FDA WARNING_LETTER - NIDEK Co., Ltd., Hamacho Plant - May 23, 2013

An FDA inspection of NIDEK Co., Ltd. in Aichi, Japan, from May 20-23, 2013, revealed that the firm's Class I and II non-sterile laser devices are adulterated. The manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation, 21 CFR Part 820. The firm's responses to the FDA 483 were not reviewed due to late submission. Key violations include: failure to establish and maintain procedures for analyzing quality data to identify nonconforming products (21 CFR 820.100(a)(1)); inadequate procedures for finished device acceptance (21 CFR 820.80(d)); failure to control all required documents (21 CFR 820.40); inadequate complaint handling procedures and maintenance of complaint files (21 CFR 820.198(a)); failure to control labeling and packaging operations and document labeling in Device History Records (21 CFR 820.120(d)); and management's failure to review the quality system's suitability and effectiveness (21 CFR 820.20(c)). NIDEK must provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for completion. Failure to correct these violations may impact federal contracts, premarket approval for Class III devices, and Certificates to Foreign Governments.