FDA WARNING_LETTER - Banyan Medical, LLC - August 24, 2015

The FDA issued a Warning Letter to Banyan Medical, LLC, following an inspection from August 11-24, 2015, at their Warwick, RI facility. The firm is a specification developer of laparoscopic cannulas and trocars, classified as medical devices. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System regulation (21 CFR Part 820).

A significant violation identified was the failure to establish and maintain procedures for validating device design to ensure conformity to user needs and intended uses, as required by 21 CFR 820.30(g). Specific deficiencies in design validation studies for Banyan Cannula and Trocar Packs included: - Lack of an approved protocol with accepted specification criteria for a "Physical Bench Testing Study" dated 2/28/2013. - Two versions of the same report, one showing failing bend test results without explanation in the other. - Lack of justification for variations in tested quantities, lengths, sideports, sterilization status, and aging conditions for compression, mechanical tensile, and mechanical puncture testing. - No comparison of results between groups to show if they were within acceptable limits. - No explanation for three failing sterile package peel strength tests in a "Shelf-Life" report dated 2/4/2013. - Failure