Roslin Cell Therapies Limited
Form 483 issued August 4, 2023 · Edinburgh, United Kingdom
- Inspection
- Jul 31 – Aug 4, 2023
- Investigators
- Carl Perez· Gregory Price· Jessica Chery
- Observations
- 2
- Pages
- 2
- FEI number
- 3013416813
In short: On August 4, 2023, FDA issued a Form 483 with 2 observations to Roslin Cell Therapies Limited in Edinburgh, Midlothian (FEI 3013416813) after an inspection that ran Jul 31 – Aug 4, 2023. The investigators were Carl Perez, Gregory Price, Jessica Chery and Zhaohui Ye. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Eauioment is not adequately…
- 02
Visual inspection process qualification…
This inspection in context
Carl Perez
7 documents · 2022–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmRoslin Cell Therapies Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roslin Cell Therapies Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Roslin Cell Therapies Limited?
Carl Perez, Gregory Price, Jessica Chery and Zhaohui Ye are named on this Form 483, for the inspection of Jul 31 – Aug 4, 2023. Each investigator has a profile showing what they cite most.
When was Roslin Cell Therapies Limited inspected by FDA?
The inspection ran Jul 31 – Aug 4, 2023, and the Form 483 is dated August 4, 2023.
How do I get the full Form 483 for Roslin Cell Therapies Limited?
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