The US Food and Drug Administration (FDA) announced last week the entry of a consent decree of permanent injunction against PharmaFab and two company officials to stop the alleged illegal manufacture and distribution of prescription and over-the-counter (OTC) drugs.
The agency found that the products were not manufactured according to the required current good manufacturing practice (cGMP) standards and many also lacked FDA approval.
The case was filed in the US District Court in Texas.
"Drug approval and cGMP compliance are part of the foundation of drug safety," Steven Galson, director of FDA's Center for Drug Evaluation and Research (CDER), said in a statement.
"When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively."
PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and OTC drugs, including cough and cold products, ulcer treatments, and postpartum haemorrhage products, the FDA said.
It also urged consumers who have drugs manufactured by PharmaFab to consult with their physician.
Affected drugs include but are not limited to: De-Congestive sustained-release capsules; GFN 1200/DM 60/PSE 60 extended-release tablets; Rhinacon A tablets; Sudal 12 chewable tablets; Histex PD 12 suspension; Atuss HX CIII Ergotrate tablets; and hyoscyamine sulfate time-release capsules.
The FDA said that because these drugs have not undergone approval, their safety and effectiveness had not been established, nor was the accuracy of the directions and warnings on their labelling.
According to the complaint filed with the courts, Texas-based PharmaFab did not comply with cGMP standards 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," the FDA said in a statement.
PharmaFAb failed to return a phone call requesting comment.
The consent decree requires PharmaFab to destroy certain illegal drugs, and bars them from distributing all drugs until they obtain FDA approval and fully comply with cGMP.
Manufacturing concerns started in 2004 when the first FDA inspection of PharmaFab's facility found that drugs being manufactured and distributed by the firm were "adulterated" in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding, did not conform to FDA regulations establishing cGMP.
The regulator said that in a follow-up inspection it spent more than 20 days scrutinising the facility from 20 March through 2 May 2006 and investigators found 21 deviations from the cGMP regulations similar to the 2004 inspection.
Following this the FDA said it issued a warning letter in 2004 to Darlene Ryan, then-president of PharmaFab, and the company "made many promises to correct their violations".
After the FDA's most recent inspection, PharmaFab once again promised to take action, said the regulator.
However, according to the FDA, despite repeated warnings and the company's subsequent promises, FDA has seen "little or no improvement" and each inspection revealed a continued inability or unwillingness to operate in compliance with the regulations.
The decree now allows the agency to require recall or shutdown in the event of future violations.
In addition, if PharmaFab does not comply with the terms of the decree, it could face damages of $5,000 (€3,600) per day and $1,000 per violation, up to a maximum of $5m per year.
" FDA will not hesitate to pursue enforcement action when necessary ," said Margaret 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."
An FDA spokesperson told Outsourcing-Pharma.com this is the third case of consent decrees involving GMP violations from a drug manufacturer the agency has had since last year.
In June last year, the agency 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.
Despite this, the regulator estimates that, in the US, perhaps as many as several thousand drug products are marketed illegally without required FDA approval.