FDA EIR - Strukmyer LLC - March 28, 2014

A Level I Quality System Inspection Technique (QSIT) inspection of Strukmyer, LLC, a medical device contract manufacturer in Mesquite, TX, was conducted by the Texas Department of State Health Services from March 24-28, 2014. The inspection, performed under federal contract and guided by Compliance Program CPGM 7382.845A, focused on management controls, corrective and preventive actions (CAPAs), and production & process controls for their Class I, 510(k) Exempt wound care dressings. Notably, no FDA Form 483 was issued, and no significant deviations from FDA Quality System Regulations (QSRs) were observed in the firm's written procedures or documentation. However, several minor verbal observations were discussed with management. These included the need to complete the product recall protocol to include FDA's 10-day notification timeline, refine the complaint handling procedure concerning investigation decisions and Medical Device Reporting requirements (21 CFR 803, 820.198(b)), and incorporate a statement in the Quality Management System explaining the lack of design controls for their Class I device (21 CFR 820.30(a)). Additional recommendations involved improving document consistency, clarifying date definitions, and updating the firm's name in its Quality Manual, reflecting administrative and clerical oversights. The company holds ISO 13485:2003 and ISO 9001:2008 certifications.