SALUS MEDICAL LLC
Form 483 issued October 24, 2024 · Phoenix, Arizona
- Inspection
- Oct 21 – Oct 24, 2024
- Investigator
- Kevin T. Nguyen
- Observations
- 2
- Pages
- 3
- FEI number
- 3014781898
In short: On October 24, 2024, FDA issued a Form 483 with 2 observations to SALUS MEDICAL LLC in Phoenix, Arizona (FEI 3014781898) after an inspection that ran Oct 21 – Oct 24, 2024. The investigator was Kevin T. Nguyen. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.22(a) (1×) · 211.142 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Procedures describing the warehousing of ding…
This inspection in context
Kevin T. Nguyen
5 documents · 2022–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Texas.
The firmSALUS MEDICAL LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SALUS MEDICAL LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected SALUS MEDICAL LLC?
Kevin T. Nguyen is named on this Form 483, for the inspection of Oct 21 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was SALUS MEDICAL LLC inspected by FDA?
The inspection ran Oct 21 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for SALUS MEDICAL LLC?
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.