Gilead Sciences ($GILD) has recalled 20 batches of its antifungal drug AmBisome after bacterial contamination was discovered during a routine test at its plant in San Dimas, CA. This plant was the subject of a 2010 FDA warning letter in which inspectors took the company to task for some of the processes and controls in its aseptic filling area.
Spokeswoman Amy Flood said in an email that the bacteria issue was discovered while the plant was doing a routine "simulation of the manufacturing processes" of AmBisome. The root cause was tracked to a valve failure, and from that the company determined that 21 batches of the drug were affected by a similar valve failure. Gilead had one of those batches still in inventory but is recalling the other 20. Five of those are being recalled from the U.K., according to an alert from the Medicines and Healthcare Products Regulatory Agency (MHRA).
"We have no evidence of any new safety signals at this stage as a consequence of a patient being exposed to product from the batches affected," Flood said.
The San Dimas facility was written up in an FDA warning letter in September 2010 for a variety of problems, including not properly cleaning equipment during the filling of AmBisome, a sterile injected drug, as well as issues with testing air flow in the aseptic filling area. The FDA also criticized the design of that area. Further, the FDA noted that while written procedures for the area call for "slow, deliberate movements during manufacturing" a fill operator was seen making "excessive body and hand movements and engaging in animated conversations" during the filling of AmBisome.
While not a huge seller for Gilead, financial filings show that AmBisome brought in $85.3 million in the first quarter of this year. This is the second product recall for Gilead in four months. In February, the company recalled a single lot of its AIDS drug Vistide after discovering some vials of the injectable medicine had particles in them. At an inspection at another plant in May the FDA also told Gilead it needed to fix quality testing issues before the agency would consider approving a pair of new drug applications.
- here's the MHRA drug alert
- here's the inspection report from the May inspection