Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-21.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 21 Jan 2025 | Biologics | 483 | View 483 → |
| 31 Jul 2023 – 4 Aug 2023 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jan 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Susan M Jackson, Peng Zhou
21 Jan 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Susan M Jackson, Peng Zhou
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson1 insp.
Peng Zhou1 insp.
Gregory A Price1 insp.
Zhaohui Ye1 insp.
Carl A Perez1 insp.
Jessica Chery1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ROSLIN CELL THERAPIES LIMITED's 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat