WARNING LETTER

CHUNGDO PHARM. CO. LTD.March 7, 2013

FDA WARNING_LETTER - CHUNGDO PHARM. CO. LTD. - March 07, 2013

FDA WARNING_LETTER for CHUNGDO PHARM. CO. LTD. on March 07, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CHUNGDO PHARM. CO. LTD. on March 07, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.100

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.90(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.90(b)(1)

21 CFR 820.30(g)

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Record Information

Company

CHUNGDO PHARM. CO. LTD.

Inspection Date

March 7, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: 69d98977-1e95-4986-97c2-e7fc23f31df8

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WARNING LETTER

CHUNGDO PHARM. CO. LTD.March 7, 2013

FDA WARNING_LETTER - CHUNGDO PHARM. CO. LTD. - March 07, 2013

FDA WARNING_LETTER for CHUNGDO PHARM. CO. LTD. on March 07, 2013. Product: Devices. 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 CHUNGDO PHARM. CO. LTD. on March 07, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.100

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.90(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.90(b)(1)

21 CFR 820.30(g)

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

CHUNGDO PHARM. CO. LTD.

Inspection Date

March 7, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: 69d98977-1e95-4986-97c2-e7fc23f31df8

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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Subscribe to our newsletter

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