The FDA also found that of the 89 ice cream production locations it investigated, 39 were deemed "Voluntary Action Indicated
," meaning that questionable conditions or practices were being observed and required voluntary action by the ice cream producer.
The FDA has issued a final classification for the inspection that occurred at PolarityTE's manufacturing facility last summer and it is now closed out with a Voluntary Action Indicated
status, Piper Jaffray analyst Tyler Van Buren tells investors in a research note titled "Consider The Key Bear Thesis Removed: Manufacturing Resolution Reached W/ FDA." The analyst believes investors can safely assume that no enforcement action will be taken or a warning letter issued.
Following each inspection, the FDA assesses the significance of the findings leading to a final classification into one of three categories no action indicated, which means the agency found no objectionable conditions during the inspection; voluntary action indicated
, which means the agency found objectionable conditions, but we are not recommending regulatory action at this time; or official action indicated, which means the agency found objectionable conditions and may pursue regulatory action.
The FDA issues three levels of response to violations: NAI (no action indicated), VAI (voluntary action indicated
), and OAI (official action indicated).
Based on separate informal correspondence received between the company and FDA staff within the Center for Biologics Evaluation and Research, the company has been informed that its compliance status is currently Voluntary Action Indicated
, which remains to be confirmed with CBER's Office of Compliance and Biologics Quality.
Additionally, the Voluntary Action Indicated
(VAI) designation we received from FDA gives us further confidence in the readiness of the manufacturing site.
MAJOR MOVERS: Among the noteworthy gainers was Achaogen (AKAO), which rose 12% after it said that the FDA has classified the outcome of its fourth quarter 2017 reinspection of Pfizer's (PFE) McPherson facility as Voluntary Action Indicated
, or VAI, thus providing a "clear regulatory path" for the approval of plazomicin out of that facility.
Achaogen (AKAO) announced that the Food and Drug Administration has classified the outcome of its fourth quarter 2017 reinspection of Pfizer's (PFE) McPherson facility as Voluntary Action Indicated
, or VAI.