FDA Inspection
Helena Laboratories UK LtdFDA Inspection 1258084 - Helena Laboratories UK Ltd - January 09, 2025
Record Details
This FDA Inspection record concerns Helena Laboratories UK Ltd, with an inspection on January 9, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8564622-d68b-4b03-a058-2b95a08d28ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258084
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Helena Laboratories UK Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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