Health Robotics Srl – FDA Warning Letter, Nov 12, 2010

On March 14, 2011, the FDA issued a Warning Letter to Health Robotics Srl following an inspection from November 8-12, 2010, at their Trieste, Italy facility. The inspection determined that their pharmacy compounding systems, CytoCare and i.v.STATION, are adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The FDA found Health Robotics Srl's December 3, 2010, response to the Form FDA 483 inadequate. Key violations included: 1. **Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g))**: No evidence of design validation in the i.v.STATION's Design History File (DHF), incomplete software validation documentation, and lack of R&D personnel retraining evidence. 2. **Failure to establish and maintain adequate procedures for verifying device design (21 CFR 820.30(f))**: DHF lacked documentation of design input, output meeting input, and verification test results. Syringe output tests lacked acceptance criteria, and air flow evaluation did not demonstrate laminar flow or air quality. 3. **