FDA EIR - Antech Diagnostics GLP - July 16, 2020

An FDA inspection of Antech Diagnostics GLP in Morrisville, NC, was conducted from July 6-16, 2020. The inspection, overseen by the Center for Veterinary Medicine (CVM) and Center for Drug Evaluation and Research (CDER), adhered to the Good Laboratory Practice (GLP) regulatory framework for nonclinical laboratories. It specifically reviewed three completed preclinical GLP studies involving clinical chemistry, hematology, and gastrin analysis. No FDA Form 483 was issued, signifying that no significant objectionable conditions or practices were observed. However, the FDA investigator discussed two key areas with laboratory management. Brief temperature excursions for refrigerators used for sample and reagent storage were noted, although these were self-corrected and confirmed not to have exceeded acceptable parameters. Additionally, management agreed to develop a formal written procedure for scanning raw data prior to sending original documents to study directors. Antech Diagnostics GLP was reminded of its ongoing responsibility to ensure compliance with all applicable GLP regulations, with the final compliance decision pending CVM and CDER review.