# FDA Inspection 1258084 - Helena Laboratories UK Ltd - January 09, 2025

Source: https://www.keypedia.com/records/fda_inspections/helena-laboratories-uk-ltd/23e018da-62ec-4778-a729-bc26072b5640
Source feed: FDA_Inspections

> FDA inspection 1258084 of Helena Laboratories UK Ltd, January 09, 2025. Classification: Voluntary Action Indicated (VAI). 3 citations under 21 CFR parts 801, 803 and 820. Form 483 issued. 1 other FDA inspection on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1258084
- Company Name: Helena Laboratories UK Ltd
- Inspection Date: 2025-01-09
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Medical Devices
- Product Type: Medical Devices & Rad Health
- Center: Medical Devices & Rad Health
- Office Name: Office of Inspections and Investigations
- Citation Count: 3

## Related Documents

- [FDA Inspection 1059203 - 2018-07-18](https://www.keypedia.com/records/fda_inspections/helena-laboratories-uk-ltd/245a04ab-0aa4-44ef-8e6c-6e9f6f74e49f)

## Related Officers

- [Company Rep](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/helena-laboratories-uk-ltd/04615ff8-2f17-4e35-abf5-8e0ae068dc55

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