Navilyst Medical, Inc. – FDA Warning Letter, May 28, 2014

This FDA Warning Letter, NYK-2015-5, issued to Navilyst Medical Inc., an AngioDynamics Company, details violations observed during inspections from April-May 2014 (Marlborough, MA) and February-March 2014 (Glens Falls, NY). The company is a specification developer and manufacturer of Vaxcel, Xcela, and Biostable (BioFlo) Peripherally Inserted Central Catheters (PICC) medical devices. These devices are deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation, 21 CFR Part 820.

Key violations at the Marlborough, MA facility include: 1. **Failure to establish and maintain procedures for verifying device design (21 CFR 820.30(f))**: Issues with seal width specifications for packaged kits, inadequate packaging design verification for protection and sterile barrier maintenance (e.g., cracked trays, holes), and insufficient accelerated/real-time aging testing procedures (e.g., out-of-tolerance humidity, product release before real-time study completion, retesting failures without documentation). 2. **Failure to establish and maintain design requirements (21 CFR 820.30(c))**: Design verification for Xcela PASV and BioFlo w/