Tuesday, August 27, 2013

Compounding Pharmacies Should Not Be Operating as Pharmaceutical Manufacturers

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC.

On October 26, 2012, the FDA issued a Form 483 with five observations to the New England Compounding Center, the company at the center of the storm of the fungal meningitis outbreak associated with more than 400 cases reported in almost 20 states with 29 deaths. During the inspection, the FDA observed contaminated products and listed a number of deficiencies regarding conditions in the clean rooms, environmental controls, and quality procedures. You can view the complete FDA Form 483 here.

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