ARL Biopharma, Inc. dba Analytical Research Laboratories
Form 483 issued September 20, 2019 · Oklahoma City, Oklahoma
- Inspection
- Aug 19 – Sep 20, 2019
- Investigator
- Margaret M. Annes
- Observations
- 1
- Pages
- 2
- FEI number
- 3003644883
In short: On September 20, 2019, FDA issued a Form 483 with 1 observation to ARL Biopharma, Inc. dba Analytical Research Laboratories in Oklahoma City, Oklahoma (FEI 3003644883) after an inspection that ran Aug 19 – Sep 20, 2019. The investigator was Margaret M. Annes. 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
For electronic laboratory equipment, your firm does not always require unique username and passwords for employees…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmARL Biopharma, Inc. dba Analytical Research Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 ARL Biopharma, Inc. dba Analytical Research Laboratories?
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 ARL Biopharma, Inc. dba Analytical Research Laboratories?
Margaret M. Annes is named on this Form 483, for the inspection of Aug 19 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was ARL Biopharma, Inc. dba Analytical Research Laboratories inspected by FDA?
The inspection ran Aug 19 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
How do I get the full Form 483 for ARL Biopharma, Inc. dba Analytical Research Laboratories?
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.