Inadequate sampling and testing has garnered Impax Labs a warning letter from the FDA for manufacturing violations. The Hayward, CA, drugmaker announced yesterday--prior to its posting on the FDA website--that it had received the warning related to an inspection that concluded in January.
The warning letter follows a March wholesale-level recall of five lots of 200-mg fenofibrate capsules. The recall of the high cholesterol treatment was prompted by inspection findings.
Impax says that since the recall, it has reduced production at the plant while it made "several key changes" to its QA system. Production levels are now back to normal.
"The deviations cited related to sampling and testing of in-process materials and drug products, production record review and our process for investigating the failure of certain manufacturing batches to meet specifications," the company says.
Impax adds that it continues to work with "leading consulting firms" it engaged after the inspection to help it review manufacturing systems and standards. "The company is committed to improving its manufacturing practices," the statement says, and "will continue to work to fully address the FDA's concerns and to resolve these issues."
- see the Impax announcement
- here's more