FDA WARNING_LETTER - Artsana S.p.A - January 27, 2011

An FDA inspection of Artsana S.p.A. in Como, Italy, from January 24-27, 2011, revealed that the firm's sterile insulin syringes and pen needles were adulterated and misbranded. The devices were adulterated because manufacturing methods, facilities, or controls did not conform to the Quality System (QS) regulation (21 CFR Part 820). Key QS violations included inadequate complaint handling procedures, insufficient process validation for sterile barrier packaging and post-sterilization processes, undocumented software validation, failure of executive management to ensure quality policy implementation, inadequate quality audit procedures, and insufficient management review of the quality system. Additionally, the devices were misbranded due to the firm's failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). The firm's response dated February 16, 2011, was deemed inadequate as it lacked documentation of corrections or systemic corrective actions. The FDA warned that premarket approvals for Class III devices and Certificates to Foreign Governments would be withheld until all violations are corrected. Artsana S.p.A. was required to provide a written response within 15 working days detailing specific corrective actions and a timetable for implementation.