Signal Medical Corporation – FDA Warning Letter, Apr 15, 2011

On June 30, 2011, the FDA issued a Warning Letter to Signal Medical Corporation following an inspection from March 17 to April 15, 2011. The inspection found that the firm's devices, including the Symmetric Total Knee System, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Nonconforming Product Control (21 CFR 820.90(b)(1)):** Failure to document justification for using nonconforming product and disposition in 12 of 70 device history records, with out-of-tolerance products released. 2. **Corrective and Preventive Action (21 CFR 820.100(a)):** Inadequate verification of CAPA effectiveness (e.g., incomplete technician training, insufficient evaluation of work orders). 3. **Process Validation (21 CFR 820.75(a)):** Lack of documentation for equipment installation, incomplete packaging validation, and failure to challenge all blister sealer parameters. 4. **Document Control (21 CFR 820.40):** Absence of approved device master records (DMRs) for several products, with unapproved records maintained on the computer system. 5