Summit Biosciences Inc.
Form 483 issued February 21, 2025 · Danbury, Connecticut
- Inspection
- Feb 18 – Feb 21, 2025
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 4
- Pages
- 9
- FEI number
- 2410990
In short: On February 21, 2025, FDA issued a Form 483 with 4 observations to Summit Biosciences Inc. in Danbury, Connecticut (FEI 2410990) after an inspection that ran Feb 18 – Feb 21, 2025. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of your quality unit to exercise its responsibility to ensure the API repackaged at your…
- 02
Your firm failed to identify and control rejected materials under a quarantine system designed to prevent…
- 04
Written procedures describing the standards, specifications, test procedures, sampling plans, and laboratory control mechanisms have not…
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 firmSummit Biosciences Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Summit Biosciences Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.
Who inspected Summit Biosciences Inc.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Feb 18 – Feb 21, 2025. Each investigator has a profile showing what they cite most.
When was Summit Biosciences Inc. inspected by FDA?
The inspection ran Feb 18 – Feb 21, 2025, and the Form 483 is dated February 21, 2025.
How do I get the full Form 483 for Summit Biosciences Inc.?
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.