Burzynski Research Institute/ IRB
Form 483 issued February 7, 2013 · Houston, Texas
- Inspection
- Jan 22 – Feb 7, 2013
- Investigators
- Andrea A. Branche· Patrick J. McNeilly
- Observations
- 7
- Pages
- 5
- FEI number
- 1000220451
In short: On February 7, 2013, FDA issued a Form 483 with 7 observations to Burzynski Research Institute/ IRB in Houston, Texas (FEI 1000220451) after an inspection that ran Jan 22 – Feb 7, 2013. The investigators were Andrea A. Branche and Patrick J. McNeilly. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.108 (iRB functions and operations).
At a glance
7 of 7 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
The IRB used an expedited review procedure for research which did not appear in an FDA…
- 02
The IRB approved the conduct of research, but did not determine that the risks to subjects…
- 0321 CFR 56.109(h)21 CFR 50
The IRB did not determine at the time of initial review that a study was in…
- 04
The IRB did not follow its written procedure for conducting…
This inspection in context
Andrea A. Branche
6 documents · 2009–2018
Cites 56.108(a)(1) (irb functions and operations) more than any other section. Most of their documents are for sites in Texas.
The firmBurzynski Research Institute/ IRB history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 56.110(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Burzynski Research Institute/ IRB?
FDA listed 7 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.108 (iRB functions and operations). The opening words of each observation are shown on this page.
Who inspected Burzynski Research Institute/ IRB?
Andrea A. Branche and Patrick J. McNeilly are named on this Form 483, for the inspection of Jan 22 – Feb 7, 2013. Each investigator has a profile showing what they cite most.
When was Burzynski Research Institute/ IRB inspected by FDA?
The inspection ran Jan 22 – Feb 7, 2013, and the Form 483 is dated February 7, 2013.
How do I get the full Form 483 for Burzynski Research Institute/ IRB?
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