FDA WARNING_LETTER - Northern Digital Inc. - March 28, 2013

On July 24, 2013, the FDA issued a Warning Letter to Northern Digital, Inc. (NDI) following a March 25-28, 2013, inspection of their Waterloo, ON facility, which manufactures Reflective Passive Marker Spheres for Image Guided Surgical Systems. The inspection found these devices 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 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate the sphere manufacturing process, especially after relocation to Mexico in 2009. IQ/OQ/PQ was not performed during the relocation or prior manufacturing in Waterloo. Corrective actions are ongoing, including a retrospective review, CAPA CAR157, and audits of the contract manufacturer, with a target completion by August 30, 2013. 2. **Design Verification (21 CFR 820.30