Sigrid Blome-Eberwein
Form 483 issued September 28, 2020 · Allentown, Pennsylvania
- Inspection
- Sep 10 – Sep 28, 2020
- Investigator
- Kelly N. Kerr
- Observations
- 1
- Pages
- 2
- FEI number
- 3017177566
In short: On September 28, 2020, FDA issued a Form 483 with 1 observation to Sigrid Blome-Eberwein in Allentown, Pennsylvania (FEI 3017177566) after an inspection that ran Sep 10 – Sep 28, 2020. The investigator was Kelly N. Kerr. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.60 (1×)
What FDA observed
Preview: the opening words of each observation- 01
An investigation was not conducted in accordance…
This inspection in context
Kelly N. Kerr
2 documents · 2019–2020
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSigrid Blome-Eberwein 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 Sigrid Blome-Eberwein?
FDA listed 1 observation 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 Sigrid Blome-Eberwein?
Kelly N. Kerr is named on this Form 483, for the inspection of Sep 10 – Sep 28, 2020. Each investigator has a profile showing what they cite most.
When was Sigrid Blome-Eberwein inspected by FDA?
The inspection ran Sep 10 – Sep 28, 2020, and the Form 483 is dated September 28, 2020.
How do I get the full Form 483 for Sigrid Blome-Eberwein?
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.