ORGANON PHARMA (UK) LIMITED
FDA inspection history in Cramlington, United Kingdom, 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 Cramlington, United Kingdom.
Cited most
Across all ORGANON PHARMA (UK) LIMITED observations on file
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete ORGANON PHARMA (UK) LIMITED file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Cramlington, United Kingdom
One Form 483 · 2025 · 3 observations
Latest: Form 483, Jun 13, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-13 | 483 Form 483 | Cramlington, United Kingdom | 3 | $99 |
Investigators on these documents
FEI number 3002807653 · most recent document Jun 13, 2025
About ORGANON PHARMA (UK) LIMITED
How many FDA Form 483s has ORGANON PHARMA (UK) LIMITED received?
FDA Intel has 1 Form 483 on file for ORGANON PHARMA (UK) LIMITED; the most recent is dated Jun 13, 2025.
When was ORGANON PHARMA (UK) LIMITED last inspected by FDA?
The most recent FDA inspection document on file for ORGANON PHARMA (UK) LIMITED is a Form 483 dated Jun 13, 2025, for the site in Cramlington, United Kingdom.
What did FDA cite at ORGANON PHARMA (UK) LIMITED?
The regulations cited most in the observations on file for ORGANON PHARMA (UK) LIMITED are 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 1 time; 21 CFR 211.84(d)(2) (Testing and approval or rejection of components, drug product containers, and closures), 1 time.