FDA WARNING_LETTER - Edge Biologicals Inc. - April 04, 2023

FDA WARNING_LETTER for Edge Biologicals Inc. on April 04, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Edge Biologicals Inc. on April 04, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.70(c)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.25(a)

21 CFR 820.80(a)

21 U.S.C. 351(h)

21 CFR 820.181

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Record Information

Company

Edge Biologicals Inc.

Inspection Date

April 4, 2023

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations Central

People

Blake Bevill (Director)

ID: da8a198e-1edb-4352-a593-f736ebbd21bb

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