FDA warns Gilead over contamination risks at California facility
pharmafile | October 25, 2010 | News story | Manufacturing and Production | AmBisome, Cayston, FDA, Gilead, Macugen, Viread, manufacturing compliance, pharma manufacturing
Gilead Sciences has been sent a warning letter from the FDA after failing to rectify problems at a facility used to manufacture its antifungal product AmBisome and HIV treatment Viread.
The plant in San Dimas, California, was inspected by the US regulator in January and February 2010, resulting in a number of Form 483 citations.
While Gilead responded to the agency with a rectification plan in March, the measures detailed were not adequate, according to the FDA’s letter.
Among the violations detailed in the letter is a failure to take adequate measures to prevent contamination occurring in aseptic processing areas.
The regulator also cited a lack of effective quality control system and inadequate environmental monitoring programmes which did not look for non-viable particulate contamination.
The FDA’s warning letter further notes Gilead did not investigate thoroughly when batches of solid dose drugs, namely Viread (tenofovir disoproxil fumarate), failed quality testing.
When faced with a situation in which tablets failed to meet cosmetic standards, the company “culled out defective tablets and packaged the remainder of the lots” without carrying out an adequate investigation into the cause, said the agency.
“Repeat observations and discussions with our office indicate that your quality unit is not adequately exercising its responsibilities,” notes the letter, adding that it “may not have appropriate authority to carry out its responsibilities”.
Gilead said in a Securities & Exchange Commission (SEC) filing ahead of the warning letter being issued that it has addressed the most serious deficiencies since its initial response to the agency and is “working diligently” to resolve any outstanding concerns.
Gilead said that until the problems are resolved to the FDA’s satisfaction, its ability to export AmBisome (liposomal amphotericin B) and other injectable products such as Cayston (aztreonam) for cystic fibrosis and eye treatment Macugen (pegaptanib sodium) could be affected.
However, as most of the issues relate to the aseptic processing areas of the San Dimas plant it does not expect any impact on its solid dose products, including Viread and its other antiviral medicines.
AmBisome brought in $155 million in the first six months of 2010, while Viread had sales of $357 million. All told the company’s antiviral franchise was worth $3.18 billion in the first half.
Phil Taylor
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