Canadian manufacturer hit with warning letter over cross-contamination issues
The FDA called Attix out for failing to avoid potential cross-contamination in the packaging of beta-lactam drug products, including penicillin and non-penicillin beta-lactams, and other drugs. The company also increased the risk of cross-contamination by allowing personnel and materials to move freely between beta-lactam and non-beta-lactam manufacturing areas.
Attix previously told inspectors that the company had ceased its penicillin operations, but the FDA said the company still manufactures other beta-lactam products beyond penicillin, “so ceasing penicillin operations is inadequate to address non-penicillin beta-lactams. You should take similar efforts to mitigate the risks of cross-contamination by non-penicillin beta-lactams, because they pose similar risks to patients.”
The agency also offers some advice for other companies that do not properly segregate beta-lactam manufacturing activities.
“Cleaning cannot substitute for proper segregation,” the FDA advises. “Cross-contamination with your sensitizing agents can initiate life-threatening allergic reactions or other drug-induced hypersensitivity reactions. Your current practices demonstrate an unacceptably high risk of beta-lactam cross-contamination into other APIs packaged at your facility. You should conduct all beta-lactam manufacturing activities in dedicated, segregated facilities with separate air handling systems and production equipment.”
In addition to the cross-contamination, the FDA identified 186 instances when Attix “inaccurately transferred quality information (manufacturer-assigned expiry dates) to your customers” without providing any scientific justification to extend the expiry dates.
The FDA warning letter also follows cross-contamination issues raised by Health Canada. In March the company had to recall all of its non-penicillin APIs repackaged and distributed between January 5, 2012 and Feb 13, 2015. The FDA said the APIs were sold to research facilities and compounding pharmacies.
In response to the warning letter, the FDA is calling on Attix to provide how it will assure that drugs manufactured at its facility following the discontinuation of penicillin repackaging will be free from beta-lactam contamination. The agency is also looking for plans for decontaminating, renovating, and requalifying Attix’s facility.
