FDA WARNING_LETTER - Tetracore, Inc. - May 28, 2009

FDA WARNING_LETTER for Tetracore, Inc. on May 28, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Tetracore, Inc. on May 28, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 820.30

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 U.S.C. 360(i)

21 CFR 820.30(c)

21 CFR 803

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Tetracore, Inc.

Inspection Date

May 28, 2009

Product Type

Devices

Office

Baltimore District Office

People

Nancy Rose (Compliance Officer)

ID: 770d0bd7-899b-4c69-8108-126b51cff23f

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