Excel Medical Products, Inc. – FDA Warning Letter, Dec 21, 2012

On April 9, 2013, the FDA issued a Warning Letter to Excel Medical Products, Inc. following an inspection from November 19 to December 21, 2012. The inspection revealed that the firm's Class II Hemostatic Y-connectors 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. **Process Validation (21 CFR 820.75(a)):** Failure to validate injection molding processes for various Y-connector components (e.g., 6 Fr. cap, rotator, Y-body components across different sizes and colors). The firm's response, indicating planned updated validations, was deemed inadequate as it involved future actions. 2. **Design History File (DHF) (21 CFR 820.30(j)):** Absence of DHFs for 4.5, 7, and 10 Fr. Hemostatic Y-connector devices. The firm's plan to compile design files after validation was not yet evaluable. 3. **Nonconforming Product Control (21 CFR 820.90(a)):** Lack of procedures for documenting and evaluating nonconforming product from production set-up. Planned new setup procedures and