On Aug. 26, 2016, Elite received a Warning Letter from the U. S. FDA regarding Postmarketing Adverse Drug Experience (PADE) reporting. According to the SEC filing, the Warning Letter relates to observations that the FDA says were inadequately addressed by the company’s response to a Form 483 issued by the FDA from a recent inspection.
The Warning Letter cites that Elite’s Standard Operating Procedures (SOPs) do not adequately address how to monitor and receive adverse drug experiences (ADEs). While Elite has a contract with an external service provider for follow-up to ADEs, Elite remains responsible for ensuring the ADEs are appropriately investigated and that follow-up information is submitted in a timely manner to the FDA. The FDA believes that Elite does not have adequate SOPS for ADEs, and failed to investigate, evaluate, and timely report ADEs.
Elite is currently addressing the deficiencies cited in the letter. The Company intends to work closely with the FDA to resolve any outstanding issues. The Warning Letter does not yet restrict the production or shipment of any of the Elite’s products, or the sale or marketing of the Company’s products.