www.fdanews.com/articles/178689-poor-ade-procedures-lead-to-warning-letter-for-elite-laboratories
Poor ADE Procedures Lead to Warning Letter for Elite Laboratories
October 4, 2016
Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs).
The FDA performed an inspection of Elite’s facility in Northvale, New Jersey, between Jan. 5 and Feb. 2.
According to the letter, Elite’s Standard Operating Procedures (SOPs) fail to address how the company receives and monitors ADE information from foreign and domestic sources.