Elite Medical Supply of New York, LLC – FDA EIR, Nov 16, 2018

An FDA Quality System Inspection of Elite Medical Supply of New York, LLC, located in Hendersonville, TN, was conducted from November 14-16, 2018. This initial inspection, focusing on the manufacturing of class II powered muscle stimulators, was performed under the regulatory framework of Compliance Program 7382.845 for medical device manufacturers. The inspection identified three significant observations, detailed on an FDA Form 483. Key violations included inadequate procedures for acceptance activities, where a failed printed circuit board subassembly was utilized in a finished device without documented resolution. Secondly, software validation for automated data processing systems supporting the quality system was not adequately documented; specifically, a critical flagging function in a build assembly form lacked validation, and off-the-shelf software was deployed in production before its formal validation. Lastly, document control procedures were deficient, as a controlled production document was used prior to its official approval and release. In response to these findings, company management committed to correcting each observation. The firm was also reminded of its continuous obligation to adhere to the Food, Drug, and Cosmetic Act and the potential regulatory actions for non-compliance.