Cyclomedica Australia Pty Limited
FDA inspection history in Kingsgrove, Australia, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at Kingsgrove, Australia.
- 2021The longest 483 on file: 13 observations over 12 pages at Kingsgrove, Australia.
Cited most
Across all Cyclomedica Australia Pty Limited observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.160General requirements2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 820.40Document controls2
- 21 CFR 820.70Production and process controls2
The complete Cyclomedica Australia Pty Limited file.
All 2 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
Kingsgrove, Australia
Two Form 483s · 2021 to 2023 · 17 observations
Latest: Form 483, Aug 8, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-08 | 483 Form 483 | Kingsgrove, Australia | 4 | $99 |
| 2021-04-06 | 483 Form 483 | Kingsgrove, Australia | 13 | $99 |
Investigators on these documents
FEI number 3009638066 · most recent document Aug 8, 2023
About Cyclomedica Australia Pty Limited
How many FDA Form 483s has Cyclomedica Australia Pty Limited received?
FDA Intel has 2 Form 483s on file for Cyclomedica Australia Pty Limited; the most recent is dated Aug 8, 2023.
When was Cyclomedica Australia Pty Limited last inspected by FDA?
The most recent FDA inspection document on file for Cyclomedica Australia Pty Limited is a Form 483 dated Aug 8, 2023, for the site in Kingsgrove, Australia.
What did FDA cite at Cyclomedica Australia Pty Limited?
The regulations cited most in the observations on file for Cyclomedica Australia Pty Limited are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.25 (Personnel qualifications), 2 times.