ORGANON PHARMA (UK) LIMITED
Form 483 issued June 13, 2025 · Cramlington, United Kingdom
- Inspection
- Jun 9 – Jun 13, 2025
- Investigator
- Khoa Nathan V. Tran
- Observations
- 3
- Pages
- 2
- FEI number
- 3002807653
In short: On June 13, 2025, FDA issued a Form 483 with 3 observations to ORGANON PHARMA (UK) LIMITED in Cramlington, Northumberland (FEI 3002807653) after an inspection that ran Jun 9 – Jun 13, 2025. The investigator was Khoa Nathan V. Tran. Most observations concern materials and quality system.
At a glance
Materials and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmORGANON PHARMA (UK) LIMITED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ORGANON PHARMA (UK) LIMITED?
FDA listed 3 observations on this Form 483, mostly about materials, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected ORGANON PHARMA (UK) LIMITED?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Jun 9 – Jun 13, 2025. Each investigator has a profile showing what they cite most.
When was ORGANON PHARMA (UK) LIMITED inspected by FDA?
The inspection ran Jun 9 – Jun 13, 2025, and the Form 483 is dated June 13, 2025.
How do I get the full Form 483 for ORGANON PHARMA (UK) LIMITED?
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.