The plant in Hayward, California was hit with the US Food and Drug Administration (FDA) warning in May 2011, after the Agency identified a number of significant GMP violations during an inspection between December 2010 and January 2011.
Impax, which develops and manufactures specialty generics, announced Tuesday it received written notice from the FDA that the Letter has been lifted following a reinspection of the site earlier this year.
“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,” CEO Fred Wilkinson said.
“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.”
Immediately following the issue of the Warning Letter, the company reduced production levels at the plant and called in consultants to help address the issues. CEO at the time, Larry Hsu, told investors the firm didn’t anticipate the manufacturing setback would delay its ongoing R&D activities.
But since then the firm has been hit with a series of other regulatory setbacks, with both the Haywood site and a manufacturing plant in Taiwan receiving several Form 483s.
Wilkinson said that with the FDA’s decision to close-out the warning, Impax is anticipating a series of new approvals and product launches from the facility, and would ramp up spending to expedite this.
“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.”