Create a free Manufacturing.net account to continue

Gilead Sciences Resolves FDA Warning Letter

The FDA had warned it about quality-control violations at a facility in San Dimas, Calif, which could have affected its ability to export drugs.

NEW YORK (AP) -- HIV drugmaker Gilead Sciences Inc. said Wednesday it has resolved the manufacturing issues that led the Food and Drug Administration to send the company a warning letter in September.

The FDA had warned it about quality-control violations at a facility in San Dimas, Calif. The violations could have affected Gilead's ability to export the antifungal drug AmBisome. The agency found the manufacturing problems during an inspection in early 2010. It later said Gilead's response to those problems was not sufficient.

AmBisome is an injectable drug, and Gilead said the problems would not have affected tablets, including its HIV drugs Atripla and Truvada.

SOURCE

More