FDA performs inspection of Impax's Taiwan facility

The US Food and Drug Administration has performed a general Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) at US generic drugmaker Impax Laboratories’ (Nasdaq: IPXL) manufacturing facility in Taiwan.

The inspections, carried out from July 21 to 26, came ahead of the company’s launch of Parkinson's disease drug Rytary (carbidopa/levodopa), which is awaiting FDA approval.

At the conclusion of the inspection, the FDA issued a Form 483 with 10 inspectional observations. The FDA did not provide any status or classification to these observations and will wait until they have received and reviewed the company's response to provide this information. Impax has also not been informed by the FDA of the impact this Form 483 may have on Rytary’s October 9 review date.