FDA WARNING_LETTER - Spartan Bioscience Inc. - December 18, 2014

The FDA issued an amended Warning Letter to Spartan Biosciences, Inc. on May 15, 2015, following a December 2014 inspection in Ottawa, Canada, concerning their Spartan RX CYP2C19 device. The letter, which includes an assessment of the firm's response to the FDA Form 483, states the device is adulterated under section 501(h) of the Act due to non-compliance with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1) Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), with inadequate documentation and implementation. 2) Failure to establish and maintain process control procedures (21 CFR 820.70(a)), evidenced by issues in manufacturing records, batch adjustments, and repeated QC testing. 3) Failure to maintain Device History Records (DHRs) (21 CFR 820.184), specifically regarding product release based on technical decisions without nonconformance reports and missing product labels. 4) Failure to establish and conduct quality audits (21 CFR 820.22), as the internal audit procedure lacked planning and no audit occurred in 2014.

The firm's responses to these observations were deemed inadequate, lacking sufficient evidence of implemented corrections, updated procedures, training, or comprehensive retrospective reviews. Spartan Biosciences must provide a written response within fifteen business days detailing corrective actions, including documentation and a timetable for systemic changes. Failure to correct these violations could impact federal contracts and prevent premarket approval for Class III devices.