FDA WARNING_LETTER - RGI Medical Manufacturing, Inc. - September 11, 2008

On December 8, 2008, the FDA issued a Warning Letter to RGI Medical Manufacturing, Inc. following an inspection from September 8-11, 2008. The inspection revealed that the firm's I.V. Administration and Extension Set, Class II 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 C.F.R. Part 820).

Key violations include: 1. **Failure to adequately validate processes (21 C.F.R. § 820.75(a))**: This includes inadequate validation of the pouch sealing process, incomplete ethylene oxide (EO) residue testing for patient-contact devices, insufficient documentation for process validation studies, and multiple deficiencies in sterilization validation (e.g., inadequate empty chamber studies, lack of heat distribution study, absence of process challenge devices, and failure to assess post-sterilization product effects). 2. **Failure to fully document employee training (21 C.F.R. § 820.25(b))**: Specifically, inadequate qualification documentation for employees performing the (b)(4) process, lack of non-visual inspection testing in training, acceptance of rejects during qualification, and insufficient retraining procedures. 3