IDT Australia Ltd. said it received a warning letter from the U.S. Food and Drug Administration regarding a December 2017 audit of its facilities.
The FDA raised concerns regarding investigations of out of specification results and deviations, plus the ability of IDT's quality system to ensure data integrity to support manufacture of its products.
The company said it has made changes including recruitment of quality and operational personnel and that it is implementing remedies that will fully address the FDA's concerns.
Australia-based IDT Australia develops and sells active pharmaceutical ingredients and finished drug products worldwide.
