FDA WARNING_LETTER - Ultroid Technologies, Inc. - April 15, 2015

On August 27, 2015, the FDA issued a Warning Letter to Ultroid Technologies, Inc. following an inspection from April 6-15, 2015. The inspection revealed that the Ultroid Hemorrhoid Management System and Procedure Kit are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)(1), (3), (4))**: The firm's Corrective Action procedure (P-852C, Rev C) lacked provisions for analyzing all quality data sources using statistical methodology to identify nonconformities. Recurring complaints regarding broken sterile packaging seals and nonconforming handles/cords were not adequately investigated to determine root causes or prevent recurrence. CAPA records also lacked documentation of verification/validation for corrective actions. 2. **Inadequate purchasing controls (21 CFR 820.50)**: The quality agreement with the contract manufacturer lacked provisions for sterilization processing controls. The contract manufacturer also failed to provide requested production records and was not registered with the FDA as a medical device manufacturer. 3. **Failure to establish and maintain design change procedures and a Design History File (D