FDA WARNING_LETTER - Stryker Corporation - November 09, 2012

The FDA issued a Warning Letter to Stryker Corporation following an October-November 2012 inspection of its Portage, Michigan facility, manufacturing Class I/II surgical devices like the Neptune Rover Waste Management System and Flyte accessories. The Neptune 2 systems were deemed misbranded (21 U.S.C. § 352(t)(2)) for failing to report a Class II recall (broken casters, tipping hazard) within 10 working days, violating 21 CFR 806.10. While Stryker reported the recall and revised procedures, FDA advised re-evaluating reporting criteria. Devices were also adulterated (21 U.S.C. § 351(h)) due to Quality System regulation non-conformities (21 CFR Part 820). Violations included inadequate design validation procedures, insufficient risk analysis documentation (21 CFR 820.30(g)), failure to establish adequate design change procedures (21 CFR 820.30(i)), and lack of routine equipment calibration procedures (21 CFR 820.72(a)). Stryker's responses were deemed inadequate as corrective actions were ongoing. Additionally, the Flyte Helmet and Neptune Silver devices were adulterated (21 U.S.C. § 351(f)(1)(B)) and misbranded (21 U.S.C. § 352(o)) for being marketed without required premarket approval (PMA) or 510(k) notifications. Stryker must respond within fifteen business days, detailing corrective actions, prevention plans, and a timetable. Non-compliance could result in regulatory actions like seizure, injunctions, civil penalties, impact on federal contracts, and denial of PMA applications or Certificates to Foreign governments, highlighting systemic quality management issues.