# FDA WARNING_LETTER - Navilyst Medical, Inc. - May 28, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/navilyst-medical-inc/a244ce4c-5bda-41df-8719-79eb0c64385a

> FDA WARNING_LETTER for Navilyst Medical, Inc. on May 28, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Navilyst Medical, Inc.
- Inspection Date: 2014-05-28
- Product Type: Devices
- Office Name: New York District Office
- Summary: 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/

## Related Officers

- [Program Director](https://www.globalkeysolutions.net/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.globalkeysolutions.net/companies/navilyst-medical-inc/d88f3551-390e-42af-9cc6-1c89aa49b656

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d