Cyclomedica Australia Pty Limited
Form 483 issued April 6, 2021 · Kingsgrove, Australia
- Inspection
- Mar 29 – Apr 6, 2021
- Investigator
- Yasamin Ameri
- Observations
- 13
- Pages
- 12
- FEI number
- 3009638066
In short: On April 6, 2021, FDA issued a Form 483 with 13 observations to Cyclomedica Australia Pty Limited in Kingsgrove, New South Wales (FEI 3009638066) after an inspection that ran Mar 29 – Apr 6, 2021. The investigator was Yasamin Ameri. Most observations concern quality system and production & process controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.160 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured. #1 (No…
- 02
Documents were not available at all locations for which they are designated…
- 03
Labels and labeling used for each finished product, lot, or batch, were not sufficiently…
- 0421 CFR 4
Procedures to control environmental conditions have…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cyclomedica Australia Pty Limited?
FDA listed 13 observations on this Form 483, mostly about quality system, production & process controls and records & documents. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cyclomedica Australia Pty Limited?
Yasamin Ameri is named on this Form 483, for the inspection of Mar 29 – Apr 6, 2021. Each investigator has a profile showing what they cite most.
When was Cyclomedica Australia Pty Limited inspected by FDA?
The inspection ran Mar 29 – Apr 6, 2021, and the Form 483 is dated April 6, 2021.
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.