SALUDA MEDICAL PTY. LTD.
FDA inspection history on file, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483.
Cited most
Across all SALUDA MEDICAL PTY. observations on file
- 21 CFR 820.70(a)Production and process controls2
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
The complete SALUDA MEDICAL PTY. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-16 | 483 Form 483 | — | 3 | $99 |
FEI number 3021836309 · most recent document May 16, 2025
About SALUDA MEDICAL PTY. LTD.
How many FDA Form 483s has SALUDA MEDICAL PTY. LTD. received?
FDA Intel has 1 Form 483 on file for SALUDA MEDICAL PTY. LTD.; the most recent is dated May 16, 2025.
When was SALUDA MEDICAL PTY. LTD. last inspected by FDA?
The most recent FDA inspection document on file for SALUDA MEDICAL PTY. LTD. is a Form 483 dated May 16, 2025.
What did FDA cite at SALUDA MEDICAL PTY. LTD.?
The regulations cited most in the observations on file for SALUDA MEDICAL PTY. LTD. are 21 CFR 820.70(a) (Production and process controls), 2 times; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.