The QMN Weekly Bulletin

FDA Inspection of Impax’s Taiwan Facility Reveals Manufacturing Issues

Aug. 8, 2014

An FDA inspection of Impax Laboratories’ Taiwan plant has uncovered apparent manufacturing violations, raising new questions about the company’s plans to launch its proposed Parkinson’s disease drug Rytary.

Investigators toured the facility July 21-26 as part of a general inspection and pre-approval check for Rytary (IPX066), the brand and generics maker said.

Among the 10 observations in the resulting Form 483 was Impax’s failure to properly validate equipment used during manufacturing of Rytary, and its failure to reject a June 2013 batch of generic acarbose, despite an unknown impurity found in the end product. Corrective steps made during the course of manufacturing also were not properly documented, the investigators said.

Impax, which makes 12 products at the plant, said it is committed to addressing the observations raised by the FDA. The company noted that the FDA has yet to assign a status or classification to the observations, and won’t do so until it has received its written response.

The company also said it has not been informed by the FDA about how the Form 483 may impact its Rytary NDA, which the agency has until Oct. 9 to review.

The company recently resubmitted the NDA after the FDA had rejected the initial application following manufacturing violations at its Hayward, Calif., facility. Impax’s repeated inability to bring that plant into compliance led GlaxoSmithKline to abandon a marketing partnership for Rytary.

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