Breaking News

Gilead Resolves FDA Observations at San Dimas Facility


Actions implemented at the site addressed manufacturing issues

Gilead Sciences, Inc. has resolved all outstanding issues raised in a Warning Letter issued by the FDA in September 2010 related to its San Dimas, CA manufacturing facility. The FDA notified Gilead that the actions adopted and implemented at the San Dimas site have sufficiently addressed the FDA’s observations, which were primarily related to the manufacturing environment for AmBisome (amphotericin B) liposome for injection, as well as general observations related to systems, procedures and con...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters