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| An Attix facility--Courtesy of Attix |
In April, Health Canada closed an active pharmaceutical ingredient repackager in Toronto and had it recall hundreds of bulk APIs that the regulators said could have been cross-contaminated by penicillin. Now the FDA has weighed in with a warning letter for the company.
According to the warning letter posted Tuesday by the FDA, Attix Pharmaceuticals failed to use separate facilities, or equipment like hoods and air handlers, to handle penicillins, non-penicillin beta-lactams, and non-beta-lactam APIs, inspectors said. The company added to the cross-contamination risk by letting employees move freely between the different areas.
Attix responded by saying everything was carefully cleaned, but the FDA said cleaning is no substitute for segregating products. "Cross-contamination with your sensitizing agents can initiate life-threatening allergic reactions or other drug-induced hypersensitivity reactions," it said. "No safe level of penicillin contamination has been determined to be a tolerable risk."
During the November visit, company officials said that Attix would be discontinuing the penicillin sales, but that is not going to cut it, the FDA said. It pointed out that the other beta-lactam products the company handles pose similar risks to patients, and so the company must take steps to avoid risks of cross-contamination by nonpenicillin beta-lactams. The agency told Attix that it needs to lay out its plans for decontaminating, renovating, and requalifying the plant.
In April, Health Canada said Attix was recalling all nonpenicillin APIs repackaged and distributed between Jan. 5, 2012, and Feb. 13, 2015. According to an FDA Enforcement Report, that adds up to 479. The FDA says they were sold to research facilities and compounding pharmacies, a part of the industry which has had its own issues.
- read the letter