AIDS drugmaker Gilead Sciences says it has cleaned its slate with the FDA. The Foster City, CA company "has resolved all outstanding issues" from a warning letter of a year ago concerning its San Dimas, CA, plant, according to a statement.
Among the issues identified in the warning were "excessive body and hand movements and animated conversations" of an aseptic fill operator in violation of procedures "to make slow, deliberate movements during manufacturing operations" to avoid microcontamination. Another citation: lack of investigation into a product failure involving tablet-process re-validation lots that repeatedly failed visual inspection. Rather than investigating the cause, operators culled defective tablets and packaged the remainder.
The warning letter also contained multiple instances of the word "inadequate" to describe Gilead's proposed fixes to shortcoming identified during the inspection.
However, Gilead has been grabbing headlines recently for its successful collaboration with Johnson & Johnson on Complera. The HIV treatment combines Gilead's Truvada and J&J's Edurant into a once-daily pill and gained FDA market approval this month.
- read the Gilead statement
- here's Warning Letter W/L 44-10 to General Manager Robert Hull
Special Report: Frightening Phrases: Warning letter language to watch