FDA 483 - IDT Australia Ltd.

An FDA inspection of IDT Australia Ltd., an Oral Solid Dosage and API Manufacturer in Boronia, Victoria, revealed significant deficiencies across multiple quality system areas. The firm failed to maintain and review raw data, lacked adequate qualified personnel, and did not follow established analytical procedures. Additionally, issues were noted with document control, computer system security, and the thoroughness of investigations into non-conforming results, indicating a systemic breakdown in GMP compliance.