FDA WARNING_LETTER - Spectrum Medical Ltd. - April 27, 2023

FDA WARNING_LETTER for Spectrum Medical Ltd. on April 27, 2023. 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 Spectrum Medical Ltd. on April 27, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 820.100(a)(4)

21 U.S.C. 360e(a)

21 CFR 807.81(a)(3)(ii)

21 U.S.C. 351(h)

21 CFR 820.100(a)(3)

21 U.S.C. 352(o)

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

Spectrum Medical Ltd.

Inspection Date

April 27, 2023

Product Type

Devices

Office

Office of Health Technology 2 (Cardiovascular Devices)

People

ID: 4da02fc1-3044-473f-8235-75be531c5ef9

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