Stanislaw R Burzynski, M.D
Form 483 issued March 15, 2013 · Houston, Maryland
- Inspection
- Jan 7 – Mar 15, 2013
- Investigators
- Cynthia F. Kleppinger· Hugh M. McClure· Joel Martinez
- Observations
- 6
- Pages
- 10
- FEI number
- 3003426453
In short: On March 15, 2013, FDA issued a Form 483 with 6 observations to Stanislaw R Burzynski, M.D in Houston, Maryland (FEI 3003426453) after an inspection that ran Jan 7 – 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 312.62 (investigator recordkeeping and record retention).
At a glance
6 of 6 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
An investigation was not conducted in accordance with the signed statement of…
- 02
Failure to prepare or maintain adequate case histories with respect to observations and data…
- 03
Failure to report promptly to the IRB all unanticipated problems involving risk to…
- 04
The informed consent document did not include a statement of any additional costs to the subject…
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 firmStanislaw R Burzynski, M.D history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stanislaw R Burzynski, M.D?
FDA listed 6 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected Stanislaw R Burzynski, M.D?
Cynthia F. Kleppinger, Hugh M. McClure and Joel Martinez are named on this Form 483, for the inspection of Jan 7 – Mar 15, 2013. Each investigator has a profile showing what they cite most.
When was Stanislaw R Burzynski, M.D inspected by FDA?
The inspection ran Jan 7 – Mar 15, 2013, and the Form 483 is dated March 15, 2013.
How do I get the full Form 483 for Stanislaw R Burzynski, M.D?
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.