FDA WARNING_LETTER - Klarity Medical Products LLC - February 25, 2020

The FDA issued a Warning Letter to Klarity Medical Products LLC following an inspection from February 10-25, 2020, at their Newark, OH facility. The inspection found that the Klarity BiteLok device is adulterated because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) and is misbranded for not submitting a 510(k) premarket notification. The FDA determined the BiteLok is a separate accessory with different indications than the previously cleared thermoplastic mask (K022708).

Additionally, "Klarity Vacuum Bags for Radiation Therapy" devices were found to be misbranded for failure to report corrections and removals, specifically an uncommunicated recall of leaking bags. The firm destroyed 321 bags due to leaks but failed to notify customers or submit an 806 report.

The inspection also revealed significant Quality System regulation violations, many of which were repeated from a May 7, 2008 Warning Letter. These include: 1. Failure to establish and maintain CAPA procedures (21 CFR § 820.100), specifically not initiating CAPAs for multiple leaking vacuum bag complaints. 2. Failure to demonstrate design controls and establish a Design History File for the BiteLok device (21 CFR § 820.30(a)-(j)). 3. Failure to establish and maintain procedures for