Company
United StatesNew Era Orthopaedics, LLc, Lake Mary, FL – FDA Inspections
Inspection records and compliance data for New Era Orthopaedics, LLc in Lake Mary, Florida. 1 FDA inspection on record, 1 Form 483, last inspected June 11, 2018.
Company Profile
This profile covers New Era Orthopaedics, LLc based in Lake Mary, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected June 11, 2018.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Design input - Lack of or inadequate procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1056379 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
New Era Orthopaedics, LLc
FEI Number
3010760160
Address
1011 Shadowmoss Cir, Lake Mary, Florida 32746, United States
Country
United States
ID: fd6cc083-5f34-4bda-bd7b-d401434ded12