Burzynski Research Institute
Form 483 issued March 15, 2013 · Houston, Texas
- Inspection
- Jan 17 – Mar 15, 2013
- Investigators
- Cynthia F. Kleppinger· Hugh M. McClure· Joel Martinez
- Observations
- 2
- Pages
- 3
- FEI number
- 3005553411
In short: On March 15, 2013, FDA issued a Form 483 with 2 observations to Burzynski Research Institute in Houston, Texas (FEI 3005553411) after an inspection that ran Jan 17 – Mar 15, 2013. The investigators were Cynthia F. Kleppinger, Hugh M. McClure and Joel Martinez. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.56 (review of ongoing investigations).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.56(a) (1×) · 312.53(c)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to monitor the progress of an investigation…
- 02
Failure to obtain from an investigator sufficient financial information to aU ow complete and accurate…
This inspection in context
Cynthia F. Kleppinger
3 documents · 2013
Cites 312.62(a) (investigator recordkeeping and record retention) more than any other section. Most of their documents are for sites in Texas.
The firmBurzynski Research Institute history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Burzynski Research Institute?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.56 (review of ongoing investigations). The opening words of each observation are shown on this page.
Who inspected Burzynski Research Institute?
Cynthia F. Kleppinger, Hugh M. McClure and Joel Martinez are named on this Form 483, for the inspection of Jan 17 – Mar 15, 2013. Each investigator has a profile showing what they cite most.
When was Burzynski Research Institute inspected by FDA?
The inspection ran Jan 17 – Mar 15, 2013, and the Form 483 is dated March 15, 2013.
How do I get the full Form 483 for Burzynski Research Institute?
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.