On September 21, 2010, Gilead Sciences (San Dimas, CA) received a warning letter from the US Food and Drug Administration, citing violations of current good manufacturing practices (cGMP) for its manufacturing and quality processes related to the production of antifungal agent AmBisome at its California facility.
The key deviation cited was that the company failed to maintain defined areas or control systems that are necessary to prevent contamination or mixups during aseptic processing. Also, the company’s environmental monitoring program was not adequate in the aseptic filling areas and the practice used to assess unidirectional airflow in the critical product path was inadequate to prevent product contamination.
Other deviations cited in the warning letter were related to inappropriate written procedures for production and process controls designed to ensure the drug product’s identity, strength, quality, and purity. The letter also said that the company had not cleaned and maintained equipment at appropriate intervals to prevent contamination.
FDA inspectors visited the plant early in the year, and Gilead responded to those concerns on March 2, 2010. The warning letter said that the response lacked sufficient corrective actions. Gilead Sciences now has 15 days to respond to the warning letter.
FDA warning letter