Howard W. Marker, M.D., Clinical Investigator
Form 483 issued May 2, 2008 · Memphis, Tennessee
- Inspection
- Apr 28 – May 2, 2008
- Investigator
- Barbara Wright
- Observations
- 2
- Pages
- 42
- FEI number
- 3004118564
In short: On May 2, 2008, FDA issued a Form 483 with 2 observations to Howard W. Marker, M.D., Clinical Investigator in Memphis, Tennessee (FEI 3004118564) after an inspection that ran Apr 28 – May 2, 2008. The investigator was Barbara Wright. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.60 (1×) · 312.62 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
, as are a back-dated record, a physical dated after the study visit and the lack…
This inspection in context
Barbara Wright
6 documents · 2000–2025
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in Alabama.
The firmHoward W. Marker, M.D., Clinical Investigator 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 Howard W. Marker, M.D., Clinical Investigator?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators). The opening words of each observation are shown on this page.
Who inspected Howard W. Marker, M.D., Clinical Investigator?
Barbara Wright is named on this Form 483, for the inspection of Apr 28 – May 2, 2008. Each investigator has a profile showing what they cite most.
When was Howard W. Marker, M.D., Clinical Investigator inspected by FDA?
The inspection ran Apr 28 – May 2, 2008, and the Form 483 is dated May 2, 2008.
How do I get the full Form 483 for Howard W. Marker, M.D., Clinical Investigator?
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.