DiaPharma Group Inc – FDA Warning Letter, Mar 8, 2011

On March 1-8, 2011, an FDA inspection of DiaPharma Group, Inc. in West Chester, Ohio, identified significant violations of the Quality System (QS) regulation (21 C.F.R. Part 820) for their in-vitro diagnostic Factor X test kits. These devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Corrective and Preventive Action (CAPA):** Inadequate procedures (SOP #820.100) failing to identify all data sources (e.g., complaints, returned product, incoming inspection reports) for non-conforming product analysis. Only management reviews and internal quality audits were listed, neither of which were consistently performed or analyzed for trends. 2. **Design Verification:** Failure to confirm design output met input requirements (21 C.F.R. § 820.30(f)). Discrepancies were noted in precision and accuracy acceptance criteria, with documented outputs not meeting established ranges or correlation coefficients. 3. **Design Validation:** Failure to conduct design validation to ensure conformity to user needs and intended uses (21 C.F.R. § 820.30(g)). Specifically, no documentation verified the product maintained its required 2-8°C temperature during shipment since its