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Major Manufacturer of Unapproved and Adulterated Drugs


warnings in their labeling.

According to the complaint filed with the court, PharmaFab did not comply with CGMP by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.

The consent decree requires the defendants to destroy certain illegal drugs, and bars them from distributing all drugs until they obtain required FDA approval and fully comply with CGMP. If they resume distributing drugs, the defendants are required to retain an auditor to conduct inspections of their facilities for a period of five years and to provide reports to FDA analyzing compliance with CGMP and labeling requirements. The decree also allows FDA to require recall or shutdown in the event of future violations and provides for damages of $5,000 per day and $1,000 per violation, up to a maximum of $5 million per year, if the defendants fail to comply with its terms.

“FDA will not hesitate to pursue enforcement action when necessary,” said Margaret O’K. Glavin, FDA's associate commissioner for regulatory affairs. “We will continue to protect public health by carefully monitoring the provisions of this injunction. FDA will also continue to investigate and take action against other marketers of unapproved drugs.”

In June 2006, FDA issued a guidance document entitled, “Marketed Unapproved Drugs—Compliance Policy Guide” (CPG). The CPG makes clear that firms may not market drugs that require approval without first establishing in applications that the products are safe and effective. One of the priorities in this CPG is enforcement actions against manufacturers that violate other provisions of the Federa
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