22nd Century Group Facility Completes FDA Inspection
22nd Century Group announced it completed an inspection from the FDA of its manufacturing facility in North Carolina.
22nd Century Group (NYSEAMERICAN:XXII) announced it completed an inspection from the US Food and Drug Administration (FDA) of its manufacturing facility in North Carolina.
As quoted in the press release:
In December of 2018, the Company submitted Modified Risk Tobacco Product (MRTP) and related PMT applications to the FDA for the Company’s VLNC cigarettes. Together, these important applications seek the FDA’s authorization to commercialize the Company’s VLN cigarettes and to communicate to consumers that VLN cigarettes contain at least 95 [percent] less nicotine as compared to the 100 leading cigarette brands in the United States.
The FDA’s inspection was a highly anticipated component of the third phase of the FDA’s four phase review process for the PMT application. The FDA’s stated goal for the inspection was “to verify the information and data contained in the [PMT] application.” As such, the FDA inspectors witnessed production of 22nd Century’s proprietary VLN cigarettes. In addition, FDA inspectors reviewed 22nd Century’s raw material receiving and storage procedures, quality control processes, manufacturing equipment and systems, tobacco processing methods, and finished-products analyses procedures.