Warren B. Shapiro, MD
Form 483 issued May 6, 2015 · Brooklyn, New York
- Inspection
- Apr 23 – May 6, 2015
- Investigator
- Tara K. Carmody
- Observations
- 3
- Pages
- 5
- FEI number
- 3011350181
In short: On May 6, 2015, FDA issued a Form 483 with 3 observations to Warren B. Shapiro, MD in Brooklyn, New York (FEI 3011350181) after an inspection that ran Apr 23 – May 6, 2015. The investigator was Tara K. Carmody. Most observations concern clinical (BIMO).
At a glance
3 of 3 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
Failure to report promptly to the sponsor adverse effects that may reasonably be regarded as caused…
- 02
An investigation was not conducted in accordance with the signed statement of…
- 03
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data…
This inspection in context
Tara K. Carmody
1 document · 2015
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in New York.
The firmWarren B. Shapiro, MD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.64(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Warren B. Shapiro, MD?
FDA listed 3 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Warren B. Shapiro, MD?
Tara K. Carmody is named on this Form 483, for the inspection of Apr 23 – May 6, 2015. Each investigator has a profile showing what they cite most.
When was Warren B. Shapiro, MD inspected by FDA?
The inspection ran Apr 23 – May 6, 2015, and the Form 483 is dated May 6, 2015.
How do I get the full Form 483 for Warren B. Shapiro, MD?
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.