FDA WARNING_LETTER - C Change Surgical, LLC - March 20, 2008

On March 11-20, 2008, an FDA inspection of a Winston-Salem, NC firm manufacturing the IntraTemp® Solution Warmer revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering the device adulterated. The firm's April 18, 2008 response to the FORM FDA 483 was largely inadequate.

Key violations include: 1. **Design History File (DHF) Deficiencies (21 CFR 820.30(j)):** The DHF lacked details on design/development changes (e.g., configuration, warnings, electrical specifications, assembly housing, dates), and the firm's response was inadequate as the marketed device differed from the 510(k) submission. 2. **Inadequate Design Verification (21 CFR 820.30(f)):** The firm failed to confirm design output met input requirements, specifically for the IntraTemp® Solution Warmer. The response was inadequate, focusing on document re-titling rather than verification. 3. **Equipment Requirements (21 CFR 820.70(g)):** Assembly verifications and operational testing were not performed for a specific IntraTemp® Model. The response was inadequate, only addressing a retest without establishing procedures. 4. **Finished Device Acceptance (21 CFR