FDA WARNING_LETTER - Exela Pharma Sciences, LLC - November 15, 2024

FDA WARNING_LETTER for Exela Pharma Sciences, LLC on November 15, 2024. 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 Exela Pharma Sciences, LLC on November 15, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 501(a)(2)(B)

21 CFR 211.166(a)

21 U.S.C. 331(a)

21 CFR 211.165(d)

21.U.S.C. 355(a)

21 U.S.C. 331(k)

21 CFR 211

21 CFR 211.194(a)(8)

21 CFR 211.167(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

Exela Pharma Sciences, LLC

Inspection Date

November 15, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: a3c42eae-44a2-43cb-aff8-83afe7e76b72

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