Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

CANCER CENTER RECEIVES FORM FDA 483 FOLLOWED BY WARNING LETTER A YEAR LATER FOR COMPROMISED ASEPTIC PROCESSING

By Leave a Comment

Over the past several years, the FDA has cited a number of Compounding Centers for compromised aseptic processing. Often this has resulted in only a Form FDA 483. In other cases the actions have resulted in both a Form FDA 483 as well as a subsequent Warning Letter. The Johnson Memorial Cancer Center is one of those that has been cited for both through a 483  and a … [Read more...]