The letter was received on August 26, according to Elite Pharmaceuticals which released details in an SEC filing last week.
“The Warning Letter relates to certain observations that the FDA believes were inadequately addressed by the Company’s response to a Form 483 issued by the FDA from a recent inspection at its facility,” the North Jersey-based drugmaker said.
“The Warning Letter cites that Elite’s Standard Operating Procedures (SOPs) do not adequately address how to monitor and receive adverse drug experiences (ADEs).”
The firm uses an undisclosed third-party for following-up to ADEs, but takes responsibility for ensuring ADEs are appropriately investigated and with information submitted in a timely manner to the FDA.
Elite “is currently addressing the deficiencies cited in the letter,” which does not restrict the firm from producing, shipping, selling or marketing its products.
The company has a number of generics on the market and its soul branded product is the OTC allergy drug Lodrane D, marketed in the US by its partner Valeant.
In related news, the firm has signed a cost and responsibility-sharing agreement with privately held company SunGen Pharma to develop and commercialise four generic pharmaceutical products.
The marketing rights on approval will be shared between Elite and SunGen, but the four products will be manufactured and packaged by Elite from its New Jersey site.
The products have not been revealed, but two are CNS stimulants and the other two are beta blockers. Total reference and generic drug sales of the four products in the US stood at over $3bn for the 12 months ending June 2016.