Abbott Point of Care Canada Limited – FDA Warning Letter, May 19, 2022

The FDA issued a Warning Letter to Edward O’Neill after a May 2022 inspection of their Ottawa, Canada facility, regarding the i-STAT cTnI Test. The device, for cardiac troponin I measurement, was found adulterated under section 501(f)(1)(B) of the Act due to lacking an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It was also misbranded under section 502(o) for failing to submit a 510(k) for significant design modifications, as required by section 510(k) and 21 CFR 807.81(a)(3).

Since 2003, the firm made multiple significant design changes to the i-STAT cTnI cartridge, including material, reagent, and sensor chip modifications. These changes significantly altered risks and could affect device safety/effectiveness, requiring new 510(k) submissions, which were not provided, rendering the current cartridge unapproved.

Devices were also adulterated under section 501(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included inadequate procedures for design change identification, documentation, validation, and approval (21 CFR 820.30(i)), as cumulative effects were not assessed. Additionally, the firm failed to adequately maintain accessible records (21 CFR 820.180), exemplified by missing original design files. The firm's FDA 483 response was deemed inadequate. Prompt corrective actions, a 15-business-day written response, and a systemic review of all device changes are mandated to prevent further regulatory action and business implications.