FDA WARNING_LETTER - Customed, Inc. - July 31, 2014

The FDA issued a Warning Letter to Customed Inc., a medical device manufacturer, following a July 2014 inspection. The firm's devices, including surgical convenience packs, were found adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System Regulation (QSR), 21 CFR Part 820. The firm's subsequent responses were deemed inadequate.

Key QSR violations included failures in process validation (EtO sterilization, 21 CFR 820.75(a)), corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), complaint investigation records (21 CFR 820.198(e)), quality system software validation (21 CFR 820.70(i)), device packaging validation (21 CFR 820.130), personnel controls (21 CFR 820.70(d)), and storage area controls (21 CFR 820.150(a)).

Additionally, devices were misbranded under 21 U.S.C. § 352(t)(2) due to inadequate Medical Device Reporting (MDR) procedures (21 CFR 803.17). Laparotomy packs were adulterated for lacking approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) (21 U.S.C. § 351(f)(1)(B)) and misbranded for failing to submit a 510(k) premarket notification (21 U.S.C. § 352(o), § 360(k)). All devices were also misbranded due to the firm's failure to fulfill annual establishment registration and device listing requirements for fiscal year 2014 (21 U.S.C. § 352(o), § 360).

Customed Inc. must correct these systemic violations within fifteen business days, providing comprehensive documentation and a timetable. Non-compliance could lead to severe regulatory actions, including seizure, injunction, civil penalties, and impact on federal contracts and product approvals.