Why didn FDA inspectors travel to Britain immediately after Chiron reported its problem in late August?
The FDA previously inspected the Liverpool plant’s manufacturing practices in June 2003, just before Chiron bought it, and raised concerns then. In 1999, the agency also warned a previous owner about quality-control problems at the plant. After Chiron disclosed its contamination problem on Aug. 26, the company said it would delay releasing any Fluvirin until it had completed more tests. FDA officials have said the contamination was caused by a bacteria called serratia marcescens, which can be deadly to people with compromised immune systems. The FDA decided to have weekly teleconference calls to monitor Chiron’s progress and await the company’s final report. Coincidentally, FDA inspectors were at the plant for another matter when Chiron announced the contamination. They “looked at the records, made some suggestions,” said acting FDA Commissioner Lester Crawford in a mid-October press conference. Then they left. When asked at that press conference whether the FDA inspectors should have
