FDA WARNING_LETTER - P.T. Sankei Medical Industries - May 11, 2023

FDA WARNING_LETTER for P.T. Sankei Medical Industries on May 11, 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 P.T. Sankei Medical Industries on May 11, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

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

21 CFR 820.30(a)

21 CFR 820.198

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

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

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

P.T. Sankei Medical Industries

Inspection Date

May 11, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e01538a1-ccc4-46b6-b20b-c8a480b76da1

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