The FDA reprimanded the Icelandic drugmaker for violating its adverse medical event reporting obligations, marketing drugs without proper clearance and causing at least 26 adverse drug experiences (ADEs) by not submitting periodic safety reports.
As a result, Actavis has said it will not produce new products at the plant until it has resolved all outstanding compliance issues to the satisfaction of the regulator, but insists the move will not impact its 2006 financial results or its guidance on growth and margins in 2007.
According to the FDA's letter, an inspection between January and February 2006 revealed that there were six potentially serious and unexpected adverse drug events dating back to 1999 for products such as digoxin, phentermine and phenazopyridine that were not reported to the agency.
The company was also chastised for manufacturing numerous prescription medicines without approved applications, including buspirone HCI tablets, carbetapentane tannate and chlorpheniramine tannate tablets, guaifenesin and pseudoephedrine HCI extended release tablets, hyoscyamine sulfate tablets and nicomide tablets.
These products appear to be unapproved new drugs introduced into interstate commerce by wrongly relying on pre-ANDA drug approval mechanisms that would characterise them as "Older Drugs."
Since the inspection, Actavis claims it has materially revised its adverse drug event and pharmacovigilence procedures to address certain deficiencies and to establish a system that ensures continuous compliance with regulatory expectations.
It insists it has also complied with all previous adverse medical event-reporting obligations that were over due or deficient.
"The management is confident that each of the identified Older Drugs are currently being marketed in accordance with applicable regulations, but is undertaking a full review of these products to address the FDA's concerns," an Actavis statement said.
"The Group is confident that based on the actions it has taken to date and its willingness to undertake any additional actions that may be required, it will fully address the concerns of the FDA."
Actavis bought the Little Falls plant in December 2005 as part of its $810m (€640m) acquisition of Alpharma's generics business.
The battle for Pliva
Meanwhile, Actavis is expected to respond in the next ten days to Barr's latest offer for Croatian drug firm Pliva which values the company slightly above $2.5bn.
The Icelandic firm believes Pliva is the next logical step in its acquisitive path, a strategy which has led to a pre-tax profit of €40.9m in the second quarter compared to €16.1m in Q2 of 2005.
The winner of the bidding war for Pliva will create the third-biggest generics firm in the world behind Israel's Teva and Switzerland's Novartis.