SALUDA MEDICAL PTY. LTD.
Form 483 issued May 16, 2025
- Inspection
- May 12 – May 16, 2025
- Observations
- 3
- Pages
- 5
- FEI number
- 3021836309
In short: On May 16, 2025, FDA issued a Form 483 with 3 observations to SALUDA MEDICAL PTY. LTD. (FEI 3021836309) after an inspection that ran May 12 – May 16, 2025. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions have…
- 02
Australia Production processes were not developed and conducted to ensure that a device…
- 03
Specifically, reportable event. For example: 04/Feb/2025. 27/Dec/2024. An MDR report was not submitted within 30 days…
This inspection in context
Questions about this 483
What did FDA find at SALUDA MEDICAL PTY. LTD.?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
When was SALUDA MEDICAL PTY. LTD. inspected by FDA?
The inspection ran May 12 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for SALUDA MEDICAL PTY. LTD.?
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.