FDA WARNING_LETTER - Sovereign Pharmaceuticals, LLC - February 02, 2012

FDA WARNING_LETTER for Sovereign Pharmaceuticals, LLC on February 02, 2012. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sovereign Pharmaceuticals, LLC on February 02, 2012. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

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

21 CFR 341.78(c)(2)

21 CFR 341.72(d)(7)

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

21 CFR 211

21 U.S.C. 321(g)(1)(B)

21 CFR 210

21 U.S.C. 321(g)(1)(C)

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Record Information

Company

Sovereign Pharmaceuticals, LLC

Inspection Date

February 2, 2012

Product Type

Drugs

Office

Dallas District Office

People

ID: 5972dc8a-0e63-4129-b0dd-b2d38e800525

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