Analytical Resource Laboratories LLC
Form 483 issued July 20, 2018 · Lehi, Utah
- Inspection
- Jul 16 – Jul 20, 2018
- Investigator
- Rumany C. Penn
- Observations
- 1
- Pages
- 3
- FEI number
- 3013019053
In short: On July 20, 2018, FDA issued a Form 483 with 1 observation to Analytical Resource Laboratories LLC in Lehi, Utah (FEI 3013019053) after an inspection that ran Jul 16 – Jul 20, 2018. The investigator was Rumany C. Penn. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAnalytical Resource Laboratories LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Analytical Resource Laboratories LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Analytical Resource Laboratories LLC?
Rumany C. Penn is named on this Form 483, for the inspection of Jul 16 – Jul 20, 2018. Each investigator has a profile showing what they cite most.
When was Analytical Resource Laboratories LLC inspected by FDA?
The inspection ran Jul 16 – Jul 20, 2018, and the Form 483 is dated July 20, 2018.
How do I get the full Form 483 for Analytical Resource Laboratories 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.