Cyclomedica Australia Pty Limited
Form 483 issued August 8, 2023 · Kingsgrove, Australia
- Inspection
- Jul 31 – Aug 8, 2023
- Investigators
- Heidy C. Perales· Marcus F. Yambot
- Observations
- 4
- Pages
- 5
- FEI number
- 3009638066
In short: On August 8, 2023, FDA issued a Form 483 with 4 observations to Cyclomedica Australia Pty Limited in Kingsgrove, New South Wales (FEI 3009638066) after an inspection that ran Jul 31 – Aug 8, 2023. The investigators were Heidy C. Perales and Marcus F. Yambot. Most observations concern production & process controls and management controls.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to control environmental conditions have…
- 02
Procedures for management review have…
- 03
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Heidy C. Perales
5 documents · 2021–2023
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in California.
The firmCyclomedica Australia Pty Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cyclomedica Australia Pty Limited?
FDA listed 4 observations on this Form 483, mostly about production & process controls, management controls and materials. The opening words of each observation are shown on this page.
Who inspected Cyclomedica Australia Pty Limited?
Heidy C. Perales and Marcus F. Yambot are named on this Form 483, for the inspection of Jul 31 – Aug 8, 2023. Each investigator has a profile showing what they cite most.
When was Cyclomedica Australia Pty Limited inspected by FDA?
The inspection ran Jul 31 – Aug 8, 2023, and the Form 483 is dated August 8, 2023.
How do I get the full Form 483 for Cyclomedica Australia Pty 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.