VitalScientific B.V. – FDA Warning Letter, Mar 30, 2017

On September 20, 2017, the FDA issued a Warning Letter to ELITech Group SAS following an inspection from March 27-30, 2017, at their Spankeren, Netherlands facility. The inspection revealed that their Selectra Pro S, Selectra Pro M, and Viva Junior Analyzer devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The devices were also misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 CFR Part 803 (Medical Device Reporting) and 21 CFR Part 806 (Reports of Corrections and Removals).

Key violations include: 1. **CAPA Procedures (21 CFR 820.100):** Failure to adequately establish and maintain CAPA procedures, including documented instructions for postponing CAPAs and disseminating information. CAPA #239 was improperly postponed and closed. 2. **Complaint Handling (21 CFR 820.198):** Inadequate procedures for receiving, reviewing, and evaluating complaints, lacking requirements for documenting oral complaints, recording reasons for non-investigation, and comprehensive investigation records. Multiple complaints were not investigated,