In Brief: Abaxis
This article was originally published in The Gray Sheet
Executive Summary
Abaxis: Firm's manufacturing facility receives Good Manufacturing Practices "in-compliance" letter from FDA, the company says Sept. 9. The correspondence resolves issues raised in a warning letter Abaxis received during its first fiscal quarter (ended June 30) relating to deficiencies in manufacturing software validation documentation. The renewed status clears the way for FDA to resume review of Abaxis' 510(k) for its gamma glutamyl transferase (GGT) test, part of the firm's Piccolo Hepatic Function Panel...