Magellan Diagnostics, Inc. – FDA 483, Jun 29, 2017

During an inspection from May 10 to June 29, 2017, the FDA observed nine violations at the firm.

**Observation 1: Design Validation Deficiencies** The firm's design validation for LeadCare II, Ultra, and Plus systems did not account for immediate analysis of blood treatment reagent mixtures, which is an intended use. Validation studies did not test under actual use conditions. The firm released LeadCare Ultra commercially in November 2013 despite a September 2013 study (VP #113) showing increased lead signal with increased incubation time. A November 2014 "Notice to Customers" instructed a 24-hour incubation for LeadCare Ultra to prevent underestimation, but this change was not validated, impacting immediate analysis needs.

**Observation 2: Inadequate Risk Analysis** Risk analyses for LeadCare Ultra, LeadCare II, and LeadCare Plus systems failed to identify or adequately evaluate the risk of falsely low test results. Documents like "LeadCare Ultra Risk Analysis" (Rev 10, 05/31/2013) and "LeadCare II Risk Analysis" (Rev 6, 09/08/2005) were not updated based on post-production information as required by SOP 159, Rev 04.

**Observation 3: Inadequate Complaint Procedures** The "Complaint Procedure" (