The FDA has issued Genzyme a warning letter due to "significant objectionable conditions" inspectors found at a company plant. The Boston site is where Genzyme produces many of it's expensive drugs, including Myozyme, Cerezyme and Fabrazyme.
The six-page letter detailed a number of technical problems that negatively impacted the quality of the products produced there. These included improper maintenance of freezers used to transport cell banks, and maintenance lapses in the computer systems used to make Fabrazyme. "The deficiencies described in this letter are indicative of your quality control unit's failure to fulfill its responsibility to assure the identity, strength, quality, and purity of your drug products and drug substances," the letter says.
Genzyme has not commented on the warning and has until March 20 to address the FDA's concerns. The WSJ says it could take three to six months for all the issues to be resolved. This means more delays for Genzyme's Myozyme, it's drug for the rare Pompe's disease. The company has been trying to ramp up production of the drug for the U.S. market, but problems at the Boston manufacturing plant have prevented more of the drug from being produced.
- here's the WSJ article