FDA WARNING_LETTER - Safe Chain Solutions, LLC - May 11, 2022

FDA WARNING_LETTER for Safe Chain Solutions, LLC on May 11, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Safe Chain Solutions, LLC on May 11, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

582(a)(6)

582(c)(4)(A)(i)(I)

21 U.S.C. 360eee-1

582(c)(4)(A)

582(c)(4)(B)(i)(I)

582(c)(4)(A)(iii)

301(t)

21 U.S.C. 331(tt)

503(e)(2)(A)

582(c)(4)(B)

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Record Information

Company

Safe Chain Solutions, LLC

Inspection Date

May 11, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: b55a786b-27f2-486d-8a11-c7445e7a537a

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