ARL Biopharma, Inc. dba Analytical Research Laboratories
Form 483 issued November 8, 2012 · Oklahoma City, Oklahoma
- Inspection
- Oct 12 – Nov 8, 2012
- Investigator
- Margaret M. Annes
- Observations
- 4
- Pages
- 2
- FEI number
- 3003644883
In short: On November 8, 2012, FDA issued a Form 483 with 4 observations to ARL Biopharma, Inc. dba Analytical Research Laboratories in Oklahoma City, Oklahoma (FEI 3003644883) after an inspection that ran Oct 12 – Nov 8, 2012. The investigator was Margaret M. Annes. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (3×) · 211.167 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm states on the Microbiology Report that is issued to a client after sterility and/or…
- 02
Your firm has no documentation to show that all analytical methods used to test for potency…
- 03
Your firm states on the Microbiology Report that is issued to a client after endotoxin testing…
- 04
Your firm has had 13 confirmed endotoxin failures for various drug products from October 2010-October 2012…
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 211.160
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 4 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). 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 Oct 12 – Nov 8, 2012. 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 Oct 12 – Nov 8, 2012, and the Form 483 is dated November 8, 2012.
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.