Agency to monitor Chiron processes as flu vaccine manufacturing resumes

摘要

Emeryville, CA—The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has restored Chiron Corp.'s (www.chiron.com) license to manufacture Fluvirin vaccine at its Liverpool, U.K., facility, but the agency will continue to monitor the company's manufacturing process remediation steps. Production of the flu vaccine was halted last fall after certain lots were found to be contaminated with the serratia marcescens bacteria—known to cause urinary tract and wound infections, as well as pneumonia, and to be resistant to antibiotics. The company was later cited by both the MHRA and the FDA for failure to adhere to several cGMPs at the Liverpool plant.