FDA Inspection
Helena Laboratories UK LtdFDA Inspection 1059203 - Helena Laboratories UK Ltd - July 18, 2018
Record Details
This FDA Inspection record concerns Helena Laboratories UK Ltd, with an inspection on July 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Helena Laboratories UK Ltd
- Inspection Date
- July 18, 2018
- Product Type
- Devices
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ID · 1f558f76-7ff7-4702-ac5a-87f077f65f20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059203
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Helena Laboratories UK Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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