# New Era Orthopaedics, LLc – FDA Inspection, Jun 11, 2018

Source: https://www.keypedia.com/records/fda_inspections/new-era-orthopaedics-llc/c51288ee-c51f-400d-842f-9e5fa970c574
Source feed: FDA_Inspections

> FDA inspection 1056379 of New Era Orthopaedics, LLc, June 11, 2018. Classification: Voluntary Action Indicated (VAI). 11 citations under 21 CFR parts 806 and 820. Form 483 issued.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1056379
- Company Name: New Era Orthopaedics, LLc
- Inspection Date: 2018-06-11
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 11

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/jacob-m-dyer/e3ca27e3-e0b1-4db8-9cbe-cfaff90b83cf)

Company: https://www.keypedia.com/companies/new-era-orthopaedics-llc/fd6cc083-5f34-4bda-bd7b-d401434ded12

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7