FDA WARNING_LETTER - Standard Textile Co Inc - February 08, 2013

An FDA inspection of Standard Textile Co., Inc. in Cincinnati, OH, conducted from February 4-8, 2013, identified significant violations regarding their circumcision and other surgical drape products. The firm's devices, specifically those manufactured with the "barrier supreme" material, were found to be adulterated under section 501(f)(1)(B) of the Act because the company lacks an approved premarket approval (PMA) application or an investigational device exemption. Furthermore, these devices are misbranded under section 502(o) of the Act and 21 C.F.R. 807.81(a)(3)(i) as the firm failed to notify the FDA of its intent to introduce the modified devices into commercial distribution, which would have required a new 510(k). This regulatory oversight stemmed from a material change made in 1994 to the "barrier supreme" device material. The FDA requires prompt corrective action, with the firm needing to notify the agency within fifteen working days of the specific steps taken to correct the violations and prevent recurrence. Failure to comply may result in severe regulatory actions, including seizure, injunction, civil money penalties, and could negatively impact the firm's eligibility for federal contracts.