“Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging – and we re-qualified and revalidated all methods used to release products from our Totowa facilities,” said Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis Inc. “This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the Consent Decree.”
The FDA completed its inspection and approved the release of the first two products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets. Subsequent inspections, also as outlined in the Decree, will follow.
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