FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024
Form 483 issued November 6, 2024 · Sandy, Utah
- Inspection
- Oct 28 – Nov 6, 2024
- Investigators
- Deepa E. Vadakkan· Emily B. Camire
- Observations
- 1
- Pages
- 3
In short: On November 6, 2024, FDA issued a Form 483 with 1 observation to FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024 in Sandy, Utah after an inspection that ran Oct 28 – Nov 6, 2024. The investigators were Deepa E. Vadakkan and Emily B. Camire. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(b)(4) are not checked…
This inspection in context
Deepa E. Vadakkan
2 documents · 2024–2026
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in Colorado.
The firmFDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024?
Deepa E. Vadakkan and Emily B. Camire are named on this Form 483, for the inspection of Oct 28 – Nov 6, 2024. Each investigator has a profile showing what they cite most.
When was FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024 inspected by FDA?
The inspection ran Oct 28 – Nov 6, 2024, and the Form 483 is dated November 6, 2024.
How do I get the full Form 483 for FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024?
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.