FDA WARNING_LETTER - Nephron Sc Inc - April 20, 2022

FDA WARNING_LETTER for Nephron Sc Inc on April 20, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Nephron Sc Inc on April 20, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 314.81(b)(1)(ii)

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

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

21 CFR 211

21 U.S.C. 355(k)

21 CFR 210

21 CFR 211.192

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

FD&C Act 503B

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Record Information

Company

Nephron Sc Inc

Inspection Date

April 20, 2022

Product Type

Drugs

Office

Office of Pharmaceutical Quality Operations Division I

People

Frances de Jesus (Acting Program Division Director)

ID: fb25266d-0c42-4d39-9684-7eafaa7ba68e

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