Strukmyer LLC – FDA EIR, May 25, 2018

An FDA surveillance inspection of Strukmyer Medical, a Mesquite, TX-based manufacturer of Class I and unclassified sterile collagen gel wound medical devices, was conducted from May 22 to May 25, 2018. The inspection, performed under Compliance Program 7382.845 for Medical Device Manufacturers and expanded to a QSIT Level 2, aimed to assess compliance with Quality System Regulations (QSR/cGMP), focusing on Management Controls, Design Controls, Corrective and Preventive Action (CAPA), and Production and Process Controls. The inspection resulted in one significant observation documented on an FDA Form 483: a failure to perform adequate risk analysis during the design and development of their Collagen Wound Dressing (K171645), as required by 21 CFR 820.30(g) and the firm's own procedures. Specifically, Product FMEA, Process FMEA, Severity, Occurrence, Detection, and Risk Priority Number were not documented. Additionally, several other issues were discussed with management, including an inadequate design control procedure, deficiencies in the Medical Device Reporting (MDR) procedure (such as missing definitions and lack of an FDA electronic submission account), the absence of a written procedure for monitoring validated processes, and referencing obsolete forms in documents. Concerns about potential mixing of sterile and non-sterile products were also raised. Strukmyer Medical's management acknowledged the observations and committed to submitting a written response addressing the Form 483 within 15 business days, with specific corrections for the risk analysis observation promised within 90 days. They also agreed to update various procedures and address the discussed items to enhance compliance. No samples were collected, and no refusals were encountered.