REYKJAVIK, Iceland, Sept. 14 (UPI) -- Icelandic generic firm Actavis said Thursday it got a warning letter from the U.S. Food and Drug Administration citing reporting violations.
Actavis Group said the FDA warning letter is based on an agency inspection of the company's manufacturing facility in Little Falls, N.J., where it makes solid oral dosage forms of generic drugs.
Actavis said the FDA warned it about its system for reporting to the agency adverse events related to use of its products.
The FDA also questioned the marketing status of some of Actavis's older drugs, which the company said it sells under the agency's regulations governing older products that have less formal application requirements.
Actavis said that, since the FDA's visit to the New Jersey plant, it has "materially revised its adverse drug event and pharmacovigilence procedures" and has complied with all reporting obligations that were overdue or deficient.
The company said it is also conducting a full review of all of its older drug products but noted it believes all such products are currently being sold in accordance with applicable regulations.
Actavis is currently involved in a bidding war with U.S. generic drug maker Barr to buy Zagreb, Croatia-based pharmaceutical firm Pliva.
