FDA EIR - Abaxis Inc - August 22, 2019

An FDA follow-up inspection of Abaxis Inc., a medical device manufacturer in Union City, CA, was conducted from August 20-22, 2019. The inspection, carried out under Compliance Program 7382.845 for Medical Device Manufacturers, focused on the company's progress in addressing previous issues and compliance with regulatory standards for their Piccolo Xpress Point-Of-Care Blood Chemistry Analyzer and Rotors. The regulatory framework applied includes 21 CFR 820.198(d), 21 CFR 803.50(a)(1), and 21 CFR 820.20(c).

The inspection identified three main violations, resulting in an FDA Form 483. First, Abaxis failed to adequately identify and submit Medical Device Reports (MDRs) for events reasonably suggesting a marketed device may have caused or contributed to serious injury, specifically citing a complaint (18-0031H) where an erroneous high potassium result from the Piccolo device led to a patient's medical intervention and hospitalization. This MDR was not filed within the required 30 days. Second, management with executive responsibility had not reviewed the suitability and effectiveness of the quality system with sufficient frequency, with no review conducted since May 2018.

Required actions include management's promise to correct the identified deficiencies, including submitting the overdue MDR. Furthermore, the company reported ongoing efforts to file a new 510(k) by November 2019 for their Piccolo Potassium Assay, addressing a prior design change made without proper regulatory clearance. They had also previously revised procedures for Design Control, Document Change Control, and Risk Management in response to an April 2019 Warning Letter.