Form 483 · FEI 3043365433
Form 483 issued April 24, 2026 · Saginaw, Michigan
- Inspection
- Apr 20 – Apr 24, 2026
- Investigator
- Stephen O. Agyemang
- Observations
- 1
- Pages
- 3
- FEI number
- 3043365433
In short: On April 24, 2026, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Saginaw, Michigan (FEI 3043365433) after an inspection that ran Apr 20 – Apr 24, 2026. The investigator was Stephen O. Agyemang. 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
Stephen O. Agyemang
1 document · 2026
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in Michigan.
The firmSite 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 an FDA-inspected site?
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 an FDA-inspected site?
Stephen O. Agyemang is named on this Form 483, for the inspection of Apr 20 – Apr 24, 2026. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 20 – Apr 24, 2026, and the Form 483 is dated April 24, 2026.
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.