Burzynski Research Institute/ IRB
FDA inspection history in Houston, Texas, 2009 to 2015
- 3
- Form 483s
Every document, by year
- Form 483
2009: one fda_correspondence; 2010: one Form 483; 2013: one Form 483; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–10One fda_correspondence and one Form 483, at Houston, Texas.
- 2013–15Two Form 483s, at Houston, Texas.
- 2013The longest 483 on file: 7 observations over 5 pages at Houston, Texas.
Cited most
Across all Burzynski Research Institute/ IRB observations on file
- 21 CFR 56.108(a)IRB functions and operations6
- 21 CFR 56.109IRB review of research3
- 21 CFR 56.115IRB records3
- 21 CFR 502
- 21 CFR 56.103Circumstances in which IRB review is required1
The complete Burzynski Research Institute/ IRB file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Houston, Texas
Three Form 483s and one fda_correspondence · 2009 to 2015 · 15 observations
Latest: Form 483, Jul 17, 2015 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-17 | 483 Form 483 | Houston, Texas | 4 | $99 |
| 2013-02-07 | 483 Form 483 | Houston, Texas | 7 | $99 |
| 2010-10-28 | 483 Form 483 | Houston, Texas | 4 | $99 |
| 2009-12-14 | fda_correspondence FDA document | Houston, Texas | — | — |
Investigators on these documents
Andrea A. Branche (2)Patrick J. McNeilly (1)Patrick Stone (1)
FEI number 1000220451 · most recent document Jul 17, 2015
About Burzynski Research Institute/ IRB
How many FDA Form 483s has Burzynski Research Institute/ IRB received?
FDA Intel has 3 Form 483s on file for Burzynski Research Institute/ IRB; the most recent is dated Jul 17, 2015.
When was Burzynski Research Institute/ IRB last inspected by FDA?
The most recent FDA inspection document on file for Burzynski Research Institute/ IRB is a Form 483 dated Jul 17, 2015, for the site in Houston, Texas.
What did FDA cite at Burzynski Research Institute/ IRB?
The regulations cited most in the observations on file for Burzynski Research Institute/ IRB are 21 CFR 56.108(a) (IRB functions and operations), 6 times; 21 CFR 56.109 (IRB review of research), 3 times; 21 CFR 56.115 (IRB records), 3 times.