Vision RT Ltd – FDA Warning Letter, Apr 17, 2013

On August 16, 2013, the FDA issued a Warning Letter to Vision RT Ltd. following an April 15-17, 2013 inspection in London, UK. The inspection revealed that Vision RT's AlignRT™ and AlignRT™ Plus patient position indicators, classified as medical device accessories, were adulterated. This means their manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Corrective and Preventive Action (CAPA) Procedures (21 CFR 820.100(a)):** Inadequate procedures for analyzing quality data, verifying CAPA effectiveness, and disseminating information. Several CAPA records were inaccurate, incomplete, or prematurely closed. 2. **Complaint Handling Procedures (21 CFR 820.198(a)):** Procedures failed to ensure evaluation for adverse events (MDR-reportable), investigation of device failures, and proper identification of MDR-reportable complaints. Reviewed complaints lacked device identification, some did not meet the complaint definition, and one support ticket was not handled as a complaint. 3. **Design Change Procedures (21 CFR 820.30(i)):** Inadequate procedures for validating/verifying design changes before implementation. Design changes were not implemented according to procedures, and some were