# FDA WARNING_LETTER - Excel Medical Products, Inc. - December 21, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/excel-medical-products-inc/a7057dc9-ebf0-4b10-b4c1-e8eb3162f2ba

> FDA WARNING_LETTER for Excel Medical Products, Inc. on December 21, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Excel Medical Products, Inc.
- Inspection Date: 2012-12-21
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: 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

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)

Company: https://www.globalkeysolutions.net/companies/excel-medical-products-inc/daa1404d-20df-4b09-8724-e77ceed73e60

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03