Form 483 · FEI 3011121261
Form 483 issued February 17, 2026 · Cleveland, Ohio
- Inspection
- Feb 9 – Feb 17, 2026
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 4
- Pages
- 8
- FEI number
- 3011121261
In short: On February 17, 2026, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Cleveland, Ohio (FEI 3011121261) after an inspection that ran Feb 9 – Feb 17, 2026. The investigator was Ucheabuchi C. Chudi-Nwankwor. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?).
What FDA observed
Preview: the opening words of each observation- 01
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by…
- 02
You did not implement procedures to ensure that all equipment is suitable for its intended purposes…
- 03
Your process controls did not include control of in-process materials to ensure that the materials are…
- 0421 CFR 361.1(d)(1)(iv)
The RDRC did not assure that the investigator utilized adequate instrumentation for the detection and measurement…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.30(a)
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. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Feb 9 – Feb 17, 2026. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 9 – Feb 17, 2026, and the Form 483 is dated February 17, 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.