A letter on the U.S. Federal Drug Administration website about contaminated products in two Apotex Inc. plants merely summarizes routine inspection findings dating back two years, says company chairman Barry Sherman. The letter says some products contained “charred” material, and raised concerns about residues on drug manufacturing equipment. The letter was prepared in advance of a meeting held earlier this month to summarize the topics of discussion, Sherman said in an interview. “We went through them at the meeting explaining everything we’ve done to correct all the observations. They’re coming back for an inspection soon which should go fine,” said Sherman. He expects to have all the issues formally resolved “within months.”

Health Canada says Apotex is “compliant” with Canadian rules. The FDA letter, dated March 29, had warned Apotex that its previous response to issues raised by inspections “is inadequate and lacks sufficient corrective action.” The letter follows up inspections dating back to 2008, which led to the U.S. banning products from two Apotex plans from entering the U.S. Among the problems previously identified: A diabetes medication was contaminated with “charred material” and other unidentified particles.

The FDA letter also says: “Your quality control unit continues to fail to perform its responsibilities regarding control and review.” “We are concerned about your inadequate and preventive maintenance and cleaning procedures and your failure to conduct a timely investigation into all equipment and products potentially affected by the deviations,” it adds. But Sherman said any inspection faults were minor: “No egregious violations, no health risks.”

For example, he said, Apotex described one of its medications in formal documents as being “white, round” tablets. But in any batch of white tablets, an occasional black speck can be found, he said. An inspection noted black specks, and pointed out that they were not mentioned in the product description. “The correction is to describe the tablet as a white, round tablet which may have occasional specks,” he said. “If the specks are known to be innocuous material, then that’s okay.”

Another issue involved residue found on some equipment. Sherman noted that Apotex had reported the issue itself. He said some residue had seeped into the driving parts of some machinery, but said the residue was not found on the areas that come in contact with the drugs themselves. The equipment has since been rebuilt to fix the problem, he said, and products made on the machinery were found to be uncontaminated.

Sherman said that if the Apotex plants had been located in the U.S., they would not have been banned from shipping products to U.S. customers, as the two Canadian Apotex plants have been. Health Canada said in an e-mailed response to questions that it is aware of the FDA letter. “Health Canada inspections of the Apotex drug manufacturing facilities in the Greater Toronto Area have resulted in a compliant inspection rating,” it said. “By definition, a compliant rating means that the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act.” “A compliant rating does not necessarily mean that there were no deficiencies noted. In situations where deficiencies are noted, corrective actions are required to be completed and this is verified by Health Canada.”

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