Siemens Healthcare Diagnostics – FDA Warning Letter, Dec 29, 2011

The FDA issued a Warning Letter to Siemens Healthcare Diagnostics following an inspection from October 24, 2011, to December 29, 2011, at their Tarrytown, New York facility, which manufactures the ADVIA Centaur iPTH immunoassay. The FDA determined these devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Design Requirements (21 CFR 820.30(c)):** Failure to establish and maintain adequate procedures for design requirements. For example, a design project lacked documentation of a formal design review at the R1 Phase, which was "N/A (Waived)." 2. **Design Review (21 CFR 820.30(e)):** Failure to ensure formal documented design reviews are planned and conducted at appropriate stages. Procedures allowed combining or eliminating design reviews, not ensuring proper review stages. 3. **Design Changes (21 CFR 820.30(i)):** Failure to establish adequate procedures for identification, documentation, validation, review, and approval of design changes. Regulatory assessments for pre-market submissions were performed before sufficient performance data was collected, and assessments were not conducted prior to implementing changes. 4. **Design