IDT Australia Limited
FDA inspection history in Boronia, Australia, 2017 to 2019
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2017: one Form 483; 2018: one close-out letter; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two close-out letters and one Form 483, at Boronia, Australia.
Cited most
Across all IDT Australia Limited observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete IDT Australia Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boronia, Australia
Two close-out letters and one Form 483 · 2017 to 2019
Latest: Close-out, Aug 27, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-27 | Close-out Close-out letter | Boronia, Australia | — | $99 |
| 2018-05-23 | Close-out Close-out letter | Boronia, Australia | — | $99 |
| 2017-12-08 | 483 Form 483 | Boronia, Australia | — | $99 |
Investigators on these documents
FEI number 3000219354 · most recent document Aug 27, 2019
About IDT Australia Limited
How many FDA Form 483s has IDT Australia Limited received?
FDA Intel has 1 Form 483 on file for IDT Australia Limited; the most recent is dated Dec 8, 2017.
When was IDT Australia Limited last inspected by FDA?
The most recent FDA inspection document on file for IDT Australia Limited is a Form 483 dated Dec 8, 2017, for the site in Boronia, Australia.
What did FDA cite at IDT Australia Limited?
The regulations cited most in the observations on file for IDT Australia Limited are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.180 (General requirements), 1 time.