WARNING LETTER

Balamurali K. Ambati , M.D., Ph.D.April 4, 2019

FDA WARNING_LETTER - Balamurali K. Ambati , M.D., Ph.D. - April 04, 2019

FDA WARNING_LETTER for Balamurali K. Ambati , M.D., Ph.D. on April 04, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Balamurali K. Ambati , M.D., Ph.D. on April 04, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 312.40(a)

21 CFR 50

21 U.S.C. 355(i)

21 CFR 320.31

21 CFR 312.20(a)

21 U.S.C. 321(g)

21 U.S.C. 355

21 CFR 56

21 CFR 312

21 CFR 312.7

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Record Information

Company

Balamurali K. Ambati , M.D., Ph.D.

Inspection Date

April 4, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 380cc958-be30-43ee-8573-0ae5efb9001c

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WARNING LETTER

Balamurali K. Ambati , M.D., Ph.D.April 4, 2019

FDA WARNING_LETTER - Balamurali K. Ambati , M.D., Ph.D. - April 04, 2019

FDA WARNING_LETTER for Balamurali K. Ambati , M.D., Ph.D. on April 04, 2019. Product: Drugs. 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 Balamurali K. Ambati , M.D., Ph.D. on April 04, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 312.40(a)

21 CFR 50

21 U.S.C. 355(i)

21 CFR 320.31

21 CFR 312.20(a)

21 U.S.C. 321(g)

21 U.S.C. 355

21 CFR 56

21 CFR 312

21 CFR 312.7

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

Balamurali K. Ambati , M.D., Ph.D.

Inspection Date

April 4, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 380cc958-be30-43ee-8573-0ae5efb9001c

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

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