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, None, 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
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| July 18, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Documents (6)
FDA Inspection 1258084 - Helena Laboratories UK Ltd - 2025-01-09
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FDA Inspection 1258084 - Helena Laboratories UK Ltd - 2025-01-09
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FDA Inspection 1258084 - Helena Laboratories UK Ltd - 2025-01-09
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FDA Inspection 1258084 - Helena Laboratories UK Ltd - 2025-01-09
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FDA Inspection 1059203 - Helena Laboratories UK Ltd - 2018-07-18
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FDA Inspection 1059203 - Helena Laboratories UK Ltd - 2018-07-18
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Search nearby companiesCompany Information
Name
Helena Laboratories UK Ltd
FEI Number
3009736003
State
None
City
Gateshead Newcastle
ID: 04615ff8-2f17-4e35-abf5-8e0ae068dc55