FDA WARNING_LETTER - Martech Mdi Inc - February 12, 2015

On April 10, 2015, the FDA issued a Warning Letter to Martech Medical Products, Inc. following an inspection from February 4-12, 2015. The inspection determined that Martech's (b)(4) devices were adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods did not conform to the Current Good Manufacturing Practice (CGMP) requirements for medical devices, specifically the Quality System regulation (21 CFR Part 820).

Violations included: 1. **Inadequate documentation of corrective and preventive action (CAPA) activities (21 CFR 820.100(b))**: Martech failed to open a CAPA for non-conforming complaint events related to their (b)(4), where tunneler sleeves were reported as "breaking" and "cracking" during catheter insertion. This circumvention prevented proper risk assessment, containment, investigation, corrective action, validation, and effectiveness checks for potential design changes. 2. **Lack of or inadequate complaint procedures (21 CFR 820.198(a))**: The firm's Complaint Management procedure lacked essential elements for evaluating and escalating complaints that might be reportable as adverse events.

Martech's written response dated March 6, 2015, was acknowledged,