FDA Finds Shocking Quality Control Problems By Generic Drugmaker
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By Lisa S. Cummings
Drug businesses can be very risky. Do you know that generic drug makers could face harsh liability for serious quality control failures? The Food and Drug Administration warns drug makers about serious violations of manufacturing rules. Since we are drug product litigators, we want to spread news about certain drug manufacturers' mistakes with the quality control of products.
A generic drugmaker, Wockhardt Ltd., has a factory in India where the FDA says that they "found urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area." We are not sure what the future FDA decisions are because they claim that they are not able to discuss potential enforcement action. The factory has responded to these reports but are still waiting for FDA decisions.