# FDA WARNING_LETTER - Aros Surgical Instruments Corporation - February 06, 2015

Source: https://www.keypedia.com/records/warning_letter/aros-surgical-instruments-corporation/ed13e767-11b3-4699-a557-023dc033a18c

> FDA WARNING_LETTER for Aros Surgical Instruments Corporation on February 06, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Aros Surgical Instruments Corporation
- Inspection Date: 2015-02-06
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: On September 25, 2015, the FDA issued a Warning Letter to Aros Surgical Instruments Corporation following a February 2-6, 2015 inspection. The inspection found that the firm's surgical sutures and micro anastomosis clamps were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1))**: No design control documentation for surgical sutures; retrospective file inadequate.
2. **Failure to control design changes (21 CFR 820.30(i))**: Implemented sterilization method changes (e.g., to E-Beam for sutures), material changes, and new designs (curved clamps, different closing forces) without proper validation, verification, or documentation.
3. **Inadequate purchasing controls (21 CFR 820.50)**: No procedures to ensure suppliers meet quality requirements.
4. **Failure to maintain supplier requirements and agreements (21 CFR 820.50(b))**: No records of specified requirements for contract manufacturers or agreements for notification of product changes.
5. **Failure to establish a design history file (21 CFR 820.

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Chief. Environmental Program Manager I](https://www.keypedia.com/people/david-mazzera/7fdf231f-4a08-4f88-b6f9-cc9b9b04eaea)

Company: https://www.keypedia.com/companies/aros-surgical-instruments-corporation/b15b94f5-6946-4eec-bdd2-978e027e243a

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b