Unisis Corporation – FDA Warning Letter, May 17, 2012

On May 14-17, 2012, an FDA inspection of Unisis Corporation in Japan, a manufacturer of single-use cannula needles, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act. The firm also failed to comply with Medical Device Reporting (MDR) requirements, leading to misbranding under section 502(t)(2).

Key violations include: 1. **Corrective and Preventive Action (CAPA) Deficiencies (21 CFR 820.100(a)):** The CAPA procedure lacked requirements for analyzing internal production nonconformance data using statistical methods and identifying recurring problems. Numerous CAPA cases remained open without adequate investigation, and corrective actions were not verified for effectiveness. 2. **Complaint Handling Deficiencies (21 CFR 820.198(a)):** The complaint handling procedure failed to require evaluation for potential Medical Device Reporting (MDR) events, and complaint investigation records lacked complainant contact information. 3. **Management Review Deficiencies (21 CFR 820.20(c)):** The management review procedure did not clearly define the interval for management review meetings. 4. **Medical Device Reporting (MDR) Procedure Deficiencies (21 CFR 803.17):** The firm