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

FDA Inspection 1258084 for Helena Laboratories UK Ltd on January 09, 2025. Classification: Voluntary Action Indicated (VAI).

View on Dashboard

One-time purchase from the GKS catalog. Lifetime access in your library. Single documents and full company profiles available. All sales final.

Record Summary

FDA Inspection 1258084 for Helena Laboratories UK Ltd on January 09, 2025. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 801.20(a)

21 CFR 803.17(a)(3)

21 CFR 820.30(f)

Get More Insights

Access our comprehensive regulatory intelligence platform to analyze patterns, track compliance trends, and stay ahead of regulatory changes.

1.5M+ regulatory data points

Real-time compliance monitoring

Interactive analytics dashboard

Looking for more records? Our platform provides access to thousands of similar regulatory documents with advanced search and filtering capabilities.

Record Information

Company

Helena Laboratories UK Ltd

Inspection Date

January 9, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f8564622-d68b-4b03-a058-2b95a08d28ad

View on Dashboard

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.

Try KeyPedia Today

Explore our real use cases and discover our features in depth.

Subscribe to our newsletter

Get the latest updates and insights delivered to your inbox