IDT Australia Ltd. said the U.S. Food and Drug Administration lifted a warning letter issued in May 2018 about the company's facilities.
The warning letter was a result of a December 2017 audit of IDT's facilities. The FDA raised concerns about IDT's out of specification results and deviations, along with the ability of the company's quality system to ensure data integrity to support manufacture of its products.
IDT Australia received a close-out letter from the FDA, which signals the resolution of the issues flagged by the regulator in its warning letter. Close-out letters are issued after the regulator completes an evaluation of corrective actions carried out by the company in response to the concerns raised in the warning letter.
Boronia, Victoria-based IDT Australia develops and sells active pharmaceutical ingredients and finished drugs worldwide.
