Form 483 · FEI 3006750659
Form 483 issued May 7, 2008 · Centennial, Colorado
- Inspection
- Apr 16 – May 7, 2008
- Investigator
- Linda M. Cherry
- Observations
- 4
- Pages
- 7
- FEI number
- 3006750659
In short: On May 7, 2008, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Centennial, Colorado (FEI 3006750659) after an inspection that ran Apr 16 – May 7, 2008. The investigator was Linda M. Cherry. Most observations concern clinical (BIMO).
At a glance
4 of 4 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to prepare or maintain accurate case histories with respect to observations and data…
- 02
Failure to report promptly to the IRB all unanticipated problems involving risk to…
- 03
An investigation was not conducted in accordance with the signed statement of…
- 04
The general requirements for informed consent were not met in that the investigator did not seek…
This inspection in context
Linda M. Cherry
2 documents · 2008–2015
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Colorado.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.62
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Linda M. Cherry is named on this Form 483, for the inspection of Apr 16 – May 7, 2008. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 16 – May 7, 2008, and the Form 483 is dated May 7, 2008.
How do I get the full Form 483 for an FDA-inspected site?
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.