FDA WARNING_LETTER - Olympus Temmo Biomaterials Corporation - Mishima Factory - October 15, 2009

An FDA inspection of Olympus Terumo Biomaterials Corporation's Mishima Factory in Shizuoka, Japan, from October 13-15, 2009, revealed that their Osferion bone void filler devices are adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 C.F.R. Part 820. The firm's November 5, 2009, response to the FDA 483 observations was deemed inadequate for all noted violations. Key deficiencies included: failure to adequately validate processes (21 C.F.R. § 820.75(a)); inadequate corrective and preventive action (CAPA) procedures (21 C.F.R. § 820.100(a)); failure to validate computer software used in production or quality systems (21 C.F.R. § 820.70(i)); unsuitable inspection, measuring, and test equipment (21 C.F.R. § 820.72(a)); absence of adequate procedures for identifying valid statistical techniques and sampling plans (21 C.F.R. § 820.250(a)); inadequate device history records (DHRs) (21 C.F.R. § 820.184(d)); and failure to establish and maintain adequate document control procedures (21 C.F.R. § 820.40(a)). The FDA requires specific corrective actions, including validation documentation, revised procedures, and retraining evidence, within fifteen working days. Non-compliance may result in regulatory actions like device detention, impact on federal contracts, premarket approval delays, and denial of Certificates to Foreign Governments. A follow-up inspection is planned.