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Pharmaceuticals / Inspections and Audits

Amneal Pharmaceuticals Cited for Tardy Submissions

March 16, 2017

The FDA served drug manufacturer Amneal Pharmaceuticals with a Form 483 after an inspection found the company failed to submit all adverse drug experience reports on time.

An August 2016 inspection revealed the manufacturer submitted six adverse drug experience reports for drugs such as tramadol HCL, acetaminophen tablets and indomethacin ER capsules, 30 days after the annual due date.

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