WARNING LETTER

SKNVJuly 15, 2016

FDA WARNING_LETTER - SKNV - July 15, 2016

FDA WARNING_LETTER for SKNV on July 15, 2016. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for SKNV on July 15, 2016. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

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

21 CFR 211

21 U.S.C. 360eee-1

21 U.S.C. 351(a)(2)(A)

21 U.S.C. 321(g)

21 U.S.C. 331(ccc)(3)

21 CFR 210

21 U.S.C. 353b

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Record Information

Company

SKNV

Inspection Date

July 15, 2016

Product Type

Drugs

Office

Florida District Office

People

Susan M. Turcovski (Deputy Program Director)

ID: 5352e047-32b9-4f8a-8c02-963f6f59dbad

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WARNING LETTER

SKNVJuly 15, 2016

FDA WARNING_LETTER - SKNV - July 15, 2016

FDA WARNING_LETTER for SKNV on July 15, 2016. 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 SKNV on July 15, 2016. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

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

21 CFR 211

21 U.S.C. 360eee-1

21 U.S.C. 351(a)(2)(A)

21 U.S.C. 321(g)

21 U.S.C. 331(ccc)(3)

21 CFR 210

21 U.S.C. 353b

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

SKNV

Inspection Date

July 15, 2016

Product Type

Drugs

Office

Florida District Office

People

Susan M. Turcovski (Deputy Program Director)

ID: 5352e047-32b9-4f8a-8c02-963f6f59dbad

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