Impax Laboratories, Inc. (NASDAQ: IPXL) today 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 by the FDA of the Hayward facility. Receipt of the FDA notice means that pursuant to the Agency's regulatory practice, the Company's remediation activities at the Company's Hayward facility and its quality management and compliance systems of the facility are 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. "We want to thank the FDA for working cooperatively with us to resolve the items previously raised by the Agency. We will remain committed to investing in our Quality Improvement Program and maintaining a culture that is focused on continuously improving these key systems."
"With the resolution of the Warning Letter, we are excited about the potential for approvals and launches of new products from this facility. While we cannot predict the timing of approvals, we are planning to accelerate certain spending initiatives during the remainder of 2015 in order to prepare for these potential events. Despite the increase in costs associated with these activities, we continue to expect that we will remain within the ranges of our previously issued guidance for full year 2015."
Wearable sensors and machine learning predict worker fatigue to improve safety and productivity