Burzynski Research Institute/ IRB
Form 483 issued July 17, 2015 · Houston, Texas
- Investigator
- Patrick Stone
- Observations
- 4
- Pages
- 2
- FEI number
- 1000220451
In short: On July 17, 2015, FDA issued a Form 483 with 4 observations to Burzynski Research Institute/ IRB in Houston, Texas (FEI 1000220451). The investigator was Patrick Stone. Most observations concern clinical (BIMO).
At a glance
4 of 4 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A clinical investigation requiring prior submission to the FDA was…
- 02
The IRB does not conduct continuing review of research at intervals ofnot less…
- 03
Copies haye not been maintained…
- 04
Documentation has not been maintained of written procedures for the IRB, as required by 21…
This inspection in context
Patrick Stone
5 documents · 2002–2015
Cites 56.103 (circumstances in which irb review is required) 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 56.103
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Burzynski Research Institute/ IRB?
FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Burzynski Research Institute/ IRB?
Patrick Stone is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Burzynski Research Institute/ IRB inspected by FDA?
This Form 483 is dated July 17, 2015.
How do I get the full Form 483 for Burzynski Research Institute/ IRB?
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.