Impax Laboratories announced that it received written notice from the United States Food and Drug Administration (FDA) verifying that the company has successfully addressed all items raised by the FDA in the May 2011 Warning Letter relating to its Hayward, California manufacturing facility.
The FDA notice follows a re-inspection in 2015 where the company’s regulatory practices, remediation activities, quality management and compliance systems were deemed to be acceptable. “Resolving the FDA Warning Letter is a testament to the progress we have made toward improving our quality and compliance systems in Hayward, with such initiatives being fully instituted across the company,” said Fred Wilkinson, President and Chief Executive Officer of Impax.