FDA warning on Genzyme Allston factory

FDA issues warning on Genzyme facility - BostonHerald.com

The Food and Drug Administration issued a warning letter to Genzyme Corp. after FDA inspectors found “significant deviations” at the biotech giant’s Allston manufacturing plant.

“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,” John R. Marzilli, the FDA’s district director for New England, wrote to Genzyme president Henri Termeer in the Feb. 27 letter.

At the Allston plant at 500 Soldiers Field Road, Genzyme did not establish or follow written sterility procedures, while making the drugs Fabrazyme, Cerezyme and Myozyme, the FDA found.

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