FDA WARNING_LETTER - Edge Pharma, LLC - August 20, 2014

FDA WARNING_LETTER for Edge Pharma, LLC on August 20, 2014. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Edge Pharma, LLC on August 20, 2014. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 CFR 211.113(b)

21 U.S.C. 321(p)

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

21 U.S.C. 331(a)

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

21 U.S.C. 331(k)

21 CFR 211

21 U.S.C. 360eee-1

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

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Record Information

Company

Edge Pharma, LLC

Inspection Date

August 20, 2014

Product Type

Drugs

Office

New England District Office

People

ID: cde15fa9-55de-4c92-83de-905476745173

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