WARNING LETTER

RC Outsourcing, LLCAugust 28, 2025

FDA WARNING_LETTER - RC Outsourcing, LLC - August 28, 2025

FDA WARNING_LETTER for RC Outsourcing, LLC on August 28, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for RC Outsourcing, LLC on August 28, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 353b(d)(4)

21 U.S.C. 321(p)

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

21 U.S.C. 331(dd)

FD&C Act 503A

FD&C Act 501

21 CFR 211.160(b)

21 CFR 211.42(c)(10)(iv)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

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Record Information

Company

RC Outsourcing, LLC

Inspection Date

August 28, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 744e0738-590c-4266-8802-661869721f50

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WARNING LETTER

RC Outsourcing, LLCAugust 28, 2025

FDA WARNING_LETTER - RC Outsourcing, LLC - August 28, 2025

FDA WARNING_LETTER for RC Outsourcing, LLC on August 28, 2025. 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 RC Outsourcing, LLC on August 28, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 353b(d)(4)

21 U.S.C. 321(p)

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

21 U.S.C. 331(dd)

FD&C Act 503A

FD&C Act 501

21 CFR 211.160(b)

21 CFR 211.42(c)(10)(iv)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

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

RC Outsourcing, LLC

Inspection Date

August 28, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 744e0738-590c-4266-8802-661869721f50

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