Company
United KingdomALBA Bioscience Limited, Penicuik, United Kingdom – FDA Inspections
Inspection records and compliance data for ALBA Bioscience Limited in Penicuik. 3 FDA inspections on record, 1 Form 483, last inspected February 21, 2025.
Company Profile
This profile covers ALBA Bioscience Limited based in Penicuik, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 31, 2018. Last inspected February 21, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 21, 2025 | Not classified | Biologics | 1258599 |
| March 17, 2023 | VAI | Biologics · Blood and Blood Products | 1200022 |
| August 31, 2018 | Not classified | Biologics | 1069657 |
FDA documents
Form 483s (1)
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Company Information
Name
ALBA Bioscience Limited
FEI Number
3011683976
Address
5 James Hamilton Way, Penicuik, United Kingdom
Country
United Kingdom
ID: 38cb6c37-00d9-460c-ad88-184f2591fbe8