FDA WARNING_LETTER - OEM Systems Co., Ltd. - October 28, 2010

On February 3, 2011, the FDA issued a Warning Letter to OEM Systems Co., Ltd. following an inspection from October 25-28, 2010, at their Uji-Shi Kyoto, Japan facility. The inspection revealed that the firm's iMark Microplate Reader, VARIANT II Hemoglobin Testing System, and VARIANT II TURBO Link devices were adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100):** The firm's CAPA procedure (GS-016/Edition 4) lacked requirements for analyzing quality data sources, investigating nonconformities, verifying/validating corrective actions, and ensuring information dissemination. Specific CAPA reports lacked documentation of verification/validation. 2. **Failure to adequately control nonconforming product (21 CFR 820.90):** The Nonconforming Product Control Procedure (GS-013 Edition 4) did not define responsibilities for review and disposition, nor did it include requirements for retesting/reevaluation after rework. Work instructions