FDA WARNING_LETTER - ECI Pharmaceuticals, LLC - March 22, 2022

FDA WARNING_LETTER for ECI Pharmaceuticals, LLC on March 22, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ECI Pharmaceuticals, LLC on March 22, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360(j)

FD&C Act 502(o)

21 U.S.C. 331(a)

21 CFR 207

FD&C Act 301(a)

FD&C Act 510(j)

21 U.S.C. 352(o)

21 U.S.C. 331(p)

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Record Information

Company

ECI Pharmaceuticals, LLC

Inspection Date

March 22, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Carolyn E. Becker

ID: ba249f39-27ff-4445-a618-e86838030f85

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