FDA WARNING_LETTER - Meridian Bioscience Inc - August 26, 2025

FDA WARNING_LETTER for Meridian Bioscience Inc on August 26, 2025. Product: Devices. Access full analysis and detailed observations.

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 WARNING_LETTER for Meridian Bioscience Inc on August 26, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

FD&C Act 501(h)

21 CFR 820.250(b)

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 803.12(a)

FD&C Act 201(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.80(b)

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

Meridian Bioscience Inc

Inspection Date

August 26, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 0489e578-4b5d-4bc8-814b-49d333503116

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