FDA WARNING_LETTER - GC America, Inc. - July 13, 2012

FDA WARNING_LETTER for GC America, Inc. on July 13, 2012. 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 GC America, Inc. on July 13, 2012. 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 U.S.C. 360e(a)

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

21 CFR 807.81(b)

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

GC America, Inc.

Inspection Date

July 13, 2012

Product Type

Devices

Office

Chicago District Office

People

Scott J. Macintire

ID: ffe8b2e0-bf56-41f0-a862-136bc5c558b9

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