Apotex Receives Closeout Letter, Resumes Shipping Generics to US

Canadian generic-drug maker Apotex has received a closeout letter from the FDA, lifting an import alert for the company’s Etobicoke, Ontario facility, and paving the way for it to resume exports to the U.S. The FDA placed two Apotex facilities — in Etobicoke and Toronto — under an import alert in 2009, following a warning letter that cited serious good manufacturing practice (GMP) deficiencies at the company’s Etobicoke plant. The FDA’s June 25, 2009, warning letter cited “multiple, serious deficiencies,” including noting that the company’s out-of-specification investigations “illustrate problems in the quality control unit’s ability to conduct thorough investigations,” according to the FDA.
Generic Line