Company
United KingdomHelena Laboratories UK Ltd - Inspection Records
Inspection records and compliance data for Helena Laboratories UK Ltd in Gateshead Newcastle. 2 FDA inspections on record, 1 Form 483, last inspected January 09, 2025.
Company Profile
This profile covers Helena Laboratories UK Ltd based in Gateshead Newcastle, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected July 18, 2018. Last inspected January 9, 2025.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design verification - output does not meet input requirement1 inspection
- Label to bear a unique device identifier1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 9, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1258084 |
| July 18, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1059203 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Company Information
Name
Helena Laboratories UK Ltd
FEI Number
3009736003
Address
Queensway South, Team Valley Trading Estate, Gateshead Newcastle, United Kingdom
Country
United Kingdom
ID: 04615ff8-2f17-4e35-abf5-8e0ae068dc55