FDA WARNING_LETTER - Jerome Stevens Pharmaceuticals, Inc - September 12, 2007

FDA WARNING_LETTER for Jerome Stevens Pharmaceuticals, Inc on September 12, 2007. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Jerome Stevens Pharmaceuticals, Inc on September 12, 2007. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 314.80(c)(2)

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

21 CFR 211

21 CFR 211.188

21 U.S.C. 331

21 CFR 210

21 CFR 314.80

21 CFR 314.80(c)(2)(ii)

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

21 U.S.C. 355(k)(1)

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Record Information

Company

Jerome Stevens Pharmaceuticals, Inc

Inspection Date

September 12, 2007

Product Type

Drugs

Office

New York District Office

People

ID: 33f358ea-7e4d-4dd7-b7ad-55f3e3a6c881

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