FDA WARNING_LETTER - Orchid Orthopedic Solutions, LLC - February 15, 2019

FDA WARNING_LETTER for Orchid Orthopedic Solutions, LLC on February 15, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Orchid Orthopedic Solutions, LLC on February 15, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.75(b)

21 CFR 820.100(a)

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 CFR 820.198(a)

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Orchid Orthopedic Solutions, LLC

Inspection Date

February 15, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: f78d7873-4f3a-4b29-95f9-4a62bf5c537d

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