FDA Inspection

Alfasigma S.p.A.November 10, 2015

FDA Inspection 951583 - Alfasigma S.p.A. - November 10, 2015

FDA Inspection 951583 for Alfasigma S.p.A. on November 10, 2015. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 951583 for Alfasigma S.p.A. on November 10, 2015. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(a)

21 CFR 211.113(b)

21 CFR 211.160(a)

21 CFR 211.160(b)(4)

21 CFR 211.28(a)

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

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Record Information

Company

Alfasigma S.p.A.

Inspection Date

November 10, 2015

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: ffb26e54-29b8-46a8-9007-e6d4a882316c

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FDA Inspection

Alfasigma S.p.A.November 10, 2015

FDA Inspection 951583 - Alfasigma S.p.A. - November 10, 2015

FDA Inspection 951583 for Alfasigma S.p.A. on November 10, 2015. Classification: Voluntary Action Indicated (VAI).

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 Inspection 951583 for Alfasigma S.p.A. on November 10, 2015. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(a)

21 CFR 211.113(b)

21 CFR 211.160(a)

21 CFR 211.160(b)(4)

21 CFR 211.28(a)

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

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

Alfasigma S.p.A.

Inspection Date

November 10, 2015

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: ffb26e54-29b8-46a8-9007-e6d4a882316c

View on Dashboard

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.

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Explore our real use cases and discover our features in depth.

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