Inke’s manufacturing plant passed its latest US FDA (US Food and Drug Administration) inspection by mid-April. The inspection resulted in no “Form 483” (no observations were noted) for the sixth consecutive time.
The inspection was carried out by the FDA inspection service from April 8 to 10, 2019 and covered cGMP (current Good Manufacturing Practices).
Inke, Neuraxpharm's APIs manufacturing plant, has a successful track record of inspections, including the inspections that the company periodically receives from the US FDA since 2002.