Summit Biosciences Inc.
FDA inspection history in Danbury, Connecticut, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Danbury, Connecticut.
Cited most
Across all Summit Biosciences observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.80General requirements1
- 21 CFR 211.89Rejected components, drug product containers, and closures1
The complete Summit Biosciences file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Danbury, Connecticut
One Form 483 · 2025 · 4 observations
Latest: Form 483, Feb 21, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-21 | 483 Form 483 | Danbury, Connecticut | 4 | $99 |
Investigators on these documents
FEI number 2410990 · most recent document Feb 21, 2025
About Summit Biosciences Inc.
How many FDA Form 483s has Summit Biosciences Inc. received?
FDA Intel has 1 Form 483 on file for Summit Biosciences Inc.; the most recent is dated Feb 21, 2025.
When was Summit Biosciences Inc. last inspected by FDA?
The most recent FDA inspection document on file for Summit Biosciences Inc. is a Form 483 dated Feb 21, 2025, for the site in Danbury, Connecticut.
What did FDA cite at Summit Biosciences Inc.?
The regulations cited most in the observations on file for Summit Biosciences Inc. are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.80 (General requirements), 1 time.