Gilead resolves warning letter form US regulatory agency

NEW YORK (AP) —Gilead Sciences Inc. announced that the manufacturing issues highlighted in the FDA warning letter in September have now been resolved.

The HIV drug maker was cautioned by the agency regarding the infringement of quality control at the San Dimas, CA facility. The US regulatory authority identified violations in the manufacturing processes during an inspection in early 2010. The severity of violations could drastically affect Gilead’s capability to export AmBisome. The agency was of the opinion that the company’s response to the critical issue was unsatisfactory.

Gilead said that AmBisome is an injectable anti-fungal drug, and tablets including HIV drugs Atripla and Truvada would not be affected.

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