# FDA 483 - IDT Australia Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/idt-australia-ltd/2575f329-c1bc-4548-b73a-61a510b12a86

> FDA 483 for IDT Australia Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IDT Australia Ltd.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2017-12-08](https://www.globalkeysolutions.net/records/warning_letter/idt-australia-ltd/eb5a0988-d6ee-4e47-a3eb-dfde73b1c43c)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/idt-australia-ltd/efc89096-ddbd-47cd-be83-bfa50b1bed16

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd