Transonic Systems Inc – FDA Warning Letter, Mar 21, 2013

This FDA Warning Letter to Transonic Systems, Inc. resulted from an inspection between February 25 and March 21, 2013, identifying significant Quality System (QS) and Medical Device Reporting (MDR) violations for their COstatus system and AV Loop Kits. The devices were deemed adulterated under 21 U.S.C. § 351(h) for non-conformity with 21 CFR Part 820 (QS regulation) and misbranded under 21 U.S.C. § 352(t)(2) for MDR failures.

Key QS violations include: * **Incomplete Design History Files (DHFs):** The COstatus system monitor and AV Loops were manufactured/released prior to required Gate 4 approval, and DHFs lacked documentation of design reviews (e.g., forms, case studies, test results). * **Inadequate Design Validation:** The COstatus system's validation failed to demonstrate conformity to user needs and intended uses, with no commitment for appropriate re-validation. * **Insufficient Software Validation Documentation:** COstatus Acquisition Software validation results for multiple monitors were not maintained, and the report lacked a documented conclusion. * **Absence of Acceptance Criteria:** Acceptance criteria were not established prior to executing verification and validation activities for the COstatus system. * **Inadequate Corrective and Preventive Actions (CAPA):** CAP