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FDAnews Drug Daily Bulletin

Poor ADE Procedures Lead to Warning Letter for Elite Laboratories

Oct. 5, 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.

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