FDA WARNING_LETTER - Captain's Cloth LLC - June 10, 2021

FDA WARNING_LETTER for Captain's Cloth LLC on June 10, 2021. 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 Captain's Cloth LLC on June 10, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 352(a)

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 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

Captain's Cloth LLC

Inspection Date

June 10, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Donna Engleman (Division Director)

ID: 4587ef81-1acb-4271-a2a4-7326ba0fffdc

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