FDA takes action against non-compliant manufacturer

The strong increase in the number of Warning Letters and further actions against non GMP compliant manufacturers show that FDA is keeping their promise to follow their enforcement strategy as published on July 15, 2010. According to this strategy paper "all FDA components are committed to swift, aggressive enforcement actions to protect the public health". It goes on by saying: "If, during an inspection, investigation and/or through a laboratory analysis, a significant violation is identified, FDA will determine as quickly as possible what further agency action might be necessary. FDA will use any and all available enforcement tools, as appropriate, based on the facts of the case and the nature and seriousness of the violation."

FDA Commissioner Dr Margret A. Hamburg stated at the Food and Drug Law Institute: "The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter."

On January 18, 2011 the US FDA obtained permanent injunction against Deltex Pharmaceuticals Inc. Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products. Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements. According to the FDA Press Release, the FDA issued a Warning Letter to Deltex for manufacturing unapproved drugs and for deviations from cGMP requirements. Since the issuance of the Warning Letter, the company continued to manufacture and distribute unapproved new drugs and continued to fail to comply with cGMP regulations. 

 Under the terms of the consent decree, the defendants cannot resume manufacturing and distributing any drug until Deltex complies with cGMP requirements. Additionally, the defendants cannot resume distributing any drug until such drug is approved by FDA or it complies with OTC drug monographs, the regulatory mechanism for legally marketing many non-prescription or OTC drugs. 

 Further, the defendants must recall drugs that were manufactured and distributed since Oct. 31, 2008 from their customers and destroy the recalled drugs, and additionally advise their customers to recall products at the retail level. The consent decree also subjects the defendants to penalties of $2,500 per day if they fail to comply with any of the provisions of the consent decree, and an additional $500 for each violation"

Source: FDA Press Release