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Gilead Resolves FDA Observations at San Dimas Facility


Actions implemented at the site addressed manufacturing issues

By: saurabh gandhe

, Rodman Media

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 controls focused on ensuring product quality at the facility.

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