Actavis Group (ICEX: ACT), the international generic pharmaceuticals company, announced today that it has received a warning letter from the U.S. Food and Drug Administration (FDA), related to its inspection of the Group's solid oral dose manufacturing facility in Little Falls, New Jersey.
The Warning Letter identifies deficiencies in the way that Actavis has handled its adverse medical event reporting obligations. The Warning Letter also questions the marketing status of certain of Actavis's older products that are currently being marketed by the Group relying on pre-ANDA drug approval mechanisms ("Older Drugs"). Since the inspection, Actavis 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. The Group has also complied with all previous adverse medical event-reporting obligations that were over due or deficient. 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.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
# posted by Network @ 4:31 AM
