IDT Australia Limited
Form 483 issued December 8, 2017 · Boronia, Australia
- Investigator
- Justin A. Boyd
- Observations
- 7
- Pages
- 6
- FEI number
- 3000219354
In short: On December 8, 2017, FDA issued a Form 483 with 7 observations to IDT Australia Limited in Boronia, Victoria (FEI 3000219354). The investigator was Justin A. Boyd. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain and…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Analytical procedures have not been established and followed. 1. There are no procedures to describe “test”…
- 04
Issuance and use of…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmIDT Australia Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IDT Australia Limited?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected IDT Australia Limited?
Justin A. Boyd is named on this Form 483. Each investigator has a profile showing what they cite most.
When was IDT Australia Limited inspected by FDA?
This Form 483 is dated December 8, 2017.
How do I get the full Form 483 for IDT Australia Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.