FDA WARNING_LETTER - Hoya Corporation - Pentax Life Division - April 24, 2015

The FDA issued a Warning Letter to Hoya Corporation (PENTAX Life Care Division) following inspections in April 2015 at their Japan facilities (Akishima-shi, Tokyo; Kurihara-shi, Miyagi) and Pentax of America, Inc. in Montvale, New Jersey. The inspections found that the firm's endoscopes and accessories were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g))**: Validation studies for ED-3670TK's EtO sterilization and cleaning/HLD IFUs used different model/series endoscopes without documented justification for applicability. EtO sterilization validation for ED-3490TK and ED-3670TK used incorrect gas concentrations. DHF lacked protocol and raw data for EtO sterilization and HLD validation reports. Reprocessing validation protocol lacked specific testing conditions (