Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-21.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Feb 2025 – 21 Feb 2025 | Biologics | Clean | |
| 9 Mar 2023 – 17 Mar 2023 | Biologics | 483 | View 483 → |
| 1 Sep 2020 – 4 Sep 2020 | Medical Devices & Rad Health | 483 | On file |
| 27 Aug 2018 – 31 Aug 2018 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2023
21 CFR 803.17(a)(1)
Lack of System for Event Evaluations
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
17 Mar 2023
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
17 Mar 2023
21 CFR 820.120
Lack of or inadequate procedures for labeling
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
17 Mar 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Richard T Riggie, Gene D Arcy, Meihong Liu, Elias N Paz Alonzo
Investigators
FDA investigators tied to this site in the record.
Richard T Riggie2 insp.
Elias N Paz Alonzo2 insp.
Meihong Liu2 insp.
Gene D Arcy1 insp.
MDSAP harperd1 insp.
Ashley J Burns1 insp.
Priscilla M Pastrana1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ALBA Bioscience 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