FDA UNTITLED_LETTER - Wedgewood Connect, LLC - November 09, 2023

FDA UNTITLED_LETTER for Wedgewood Connect, LLC on November 09, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA UNTITLED_LETTER for Wedgewood Connect, LLC on November 09, 2023. 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 CFR 211.165(d)

21 U.S.C. 331(k)

21 U.S.C. 360eee-1

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

21 U.S.C. 321(g)

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Record Information

Company

Wedgewood Connect, LLC

Inspection Date

November 9, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: c7b71d6a-971e-480f-9e52-95939c6a80af

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