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Pulmozyme |
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No references found | FDA's August 2000 inspection of Genentech of South San Francisco disclosed substantial problems with the firm's GMP compliance work that showed up as out-of-specification (OOS) outcomes for particulate matter and led to a recall of over 200,000 doses of Pulmozyme (dornase alfa) in October. Field investigator Mariza Jafary wrote in the EIR that the comprehensive GMP audit was part of the Center for Biologics' Fiscal Year 2000 workplan, but the inspection disclosed that the firm experienced substantial problems in production of Pulmozyme (dornase alfa) that led to a recall of 200,000 doses of the drug in October. The letter stated that Genentech had released two thawed lots of Pulmozyme bulk that the firm re-filtered after "brown foreign material and brown particulates were observed" and that the firm had no documentation indicating that personnel notified the quality control unit prior to re-filtration of one lot of Activase involved with a leak in filling equipment. |
Pulmozyme |
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