FDA WARNING_LETTER - Terumo Medical Products Hangzhou Co., Ltd. - December 16, 2012

The FDA issued a Warning Letter to Terumo Medical Products Hangzhou Company, Limited following an inspection from December 12, 2011, to December 16, 2012, at their Hangzhou, China facility. The inspection revealed that the firm's Surshield Safety Winged intravenous infusion and blood collection sets are adulterated under section 501(h) of the Act, as manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: failure to adequately validate processes (21 CFR 820.75(a)), specifically unvalidated skin puncture and needle/wing bonding test methods; failure to control nonconforming product (21 CFR 820.90(a)) with undocumented production failures; failure to establish adequate rework procedures (21 CFR 820.90(b)(2)) by not documenting rework in Device History Records; failure to identify valid statistical techniques (21 CFR 820.250(a)) for process capability; and failure to ensure test equipment suitability (21 CFR 820.72(a)), lacking evidence for (b)(4) test equipment validity.

The firm's January 6, 2012, response was deemed inadequate for all observations, lacking sufficient evidence of completed corrective actions, training, or systemic reviews. Terumo must provide a written response within fifteen business days detailing specific, systemic corrective actions, supporting documentation, and a timetable for completion. Failure to correct these violations may result in refusal of admission for their devices, detention without physical examination, impact on federal contracts, and denial of premarket approvals and Certificates to Foreign Governments.