FDA WARNING_LETTER - Safecor Health, LLC - March 16, 2023

FDA WARNING_LETTER for Safecor Health, LLC on March 16, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Safecor Health, LLC on March 16, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211

21 CFR 211.130(e)

21 CFR 210

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

21 CFR 211.22

21 CFR 211.84(d)(2)

21 CFR 211.67(b)

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Record Information

Company

Safecor Health, LLC

Inspection Date

March 16, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: 8521ff6d-bf16-4bb3-ae52-3f065864a452

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