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FDA Comes Down on Contamination Risks at Genentech Avastin Plant

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Genentech may need to tune up manufacturing practices at a San Francisco, Calif., plant that makes cancer drug Avastin. The FDA found several contamination risks during a recent inspection, including some it has pointed out before, according to a Form 483. For example, a Genentech investigation into disintegrating gaskets did not require employees to compare particulates in finished vials of Avastin (bevacizumab) with the identified gasket material. In the capping area, there appeared to be a gap between the HEPA filter coverage and the semi-permanent plastic barriers. This gap seemed to allow outside air to pass over the vials, according to the Sept. 27, 2011, form posted online last month.
Drug GMP Report