FDA Inspection 1056379 - New Era Orthopaedics, LLc - June 11, 2018

Record Details

This FDA Inspection record concerns New Era Orthopaedics, LLc, with an inspection on June 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: New Era Orthopaedics, LLc
Inspection Date: June 11, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 0545081a-5f7a-4b14-be7f-12773245fa3a

Violation Codes10

21 CFR 806.10(b)21 CFR 820.100(a)21 CFR 820.18121 CFR 820.30(c)21 CFR 820.30(f)21 CFR 820.30(g)21 CFR 820.30(h)21 CFR 820.4021 CFR 820.5021 CFR 820.70(e)

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