Oy Ajat Ltd – FDA Warning Letter, Oct 11, 2012

On October 8-11, 2012, an FDA inspection of Oy Ajat Ltd. in Espoo, Finland, identified that their solid state x-ray imagers, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 USC 352 (t)(2) for failing to furnish required information under 21 USC 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Design Control (21 CFR 820.30(a)):** Failure to establish adequate procedures for design validation (lacking risk analysis inclusion and defined operational conditions), design verification (not ensuring design outputs satisfy inputs), and design reviews (not documenting coverage of required topics like requirement specifications and risk analysis). The firm's response was inadequate, lacking updated procedures and systemic corrective actions. 2. **Quality Audits (21 CFR 820.22):** Internal quality audit procedure 101 did not require re-auditing deficient areas. While an updated procedure was provided, systemic corrective action for assessing previous audits was missing. 3. **Device History Records (DHRs) (21