Company
United StatesDNE LLC, Boca Raton, FL – FDA Inspections
Inspection records and compliance data for DNE LLC in Boca Raton, Florida. 1 FDA inspection on record, 1 Form 483, last inspected April 06, 2018.
Company Profile
This profile covers DNE LLC based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 6, 2018.
Most cited issue areas
- Lack of System for Determining MDR Events1 inspection
- Quality Audit/Reaudit - conducted1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1047161 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DNE LLC
FEI Number
3009763359
Address
902 Clint Moore Rd Ste 206, Boca Raton, Florida 33487, United States
Country
United States
ID: 5e46fc66-8a6b-4973-a421-95bd0352cc64