US FDA says Elite has addressed adverse event monitoring concerns

By Gareth Macdonald contact

- Last updated on GMT


Related tags: U.s. securities and exchange commission, Fda

The US FDA says Elite Pharmaceuticals Inc. has addressed drug safety monitoring shortcomings that earned it a warning letter in 2016.

Elite announced its receipt of a close out letter this week in a US Securities and Exchange Commission (SEC), explaining that the agency is satisfied corrective measures have addressed the problems.

The firm wrote, “The FDA has concluded its evaluation and the corrective actions undertaken by the Company are now complete. There are no longer any potential restrictions from the Warning Letter. Elite remains responsible to continue to maintain compliance with FDA regulations​.”

Elite also confirmed it had passed a pre-approval inspection earlier this month. It said, “The inspection was classified as ‘No Action Indicated’ (NAI) because the FDA did not issue any observations​.”

The US Food and Drug Administration (FDA) issued Elite with the warning letter last August​ after an inspection at its facility in Northvale, New Jersey.

Related topics: Markets & Regulations, Regulations

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