Production line in San Dimas
Gilead, which is reshaping its massive Foster City headquarters campus, this year added a new, s more-automated production line in San Dimas for the inhaled cystic fibrosis treatment Cayston.
Gilead has produced Cayston, the HIV drug Viread, the antifungal drug AmBisome and the injectable wet age-related macular degeneration drug Macugen at the San Dimas plant.
The San Dimas facility was the focus of a Food and Drug Administration warning letter in 2010 that raised concerns about the manufacturing environment for AmBisome, quality procedures and controls for Viread and "a generalized concern over the effectiveness of the San Dimas quality unit in carrying out its responsibilities."
Delays with the expansion of manufacturing Cayston at San Dimas and in qualifying two other sites, Gilead for seven months in 2012 suspended access for patients with new prescriptions for the drug.
Gilead has another Southern California manufacturing site in Oceanside.