The FDA has warned the company for not adhering current good manufacturing practice (cGMP) for finished pharmaceuticals.
The FDA has found deviations related to sampling and testing of in process materials and drug products, production record review and their process for investigating the failure of certain manufacturing batches (or portions of batches) to meet specifications.
Impax will continue to work to fully address the FDA’s concerns and to resolve these issues.
The company will respond to the FDA’s warning letter within the mandated 15 business day response period.
Impax president and CEO Larry Hsu said they intend to promptly respond to the FDA’s letter, and have already begun to implement changes and establish procedures that address the observations cited during the inspection.
"We will work diligently to remedy any outstanding issues in a timely manner," Hsu said.
"We don’t anticipate that this manufacturing setback will delay our ongoing research and development activities."