Company
United StatesEnercon, Gray, ME – FDA Inspections
Inspection records and compliance data for Enercon in Gray, Maine. 2 FDA inspections on record, 1 Form 483, last inspected April 19, 2023.
Company Profile
This profile covers Enercon based in Gray, Maine, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 3, 2017. Last inspected April 19, 2023.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 19, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1204697 |
| August 3, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1020325 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Enercon
FEI Number
3003018722
Address
25 Northbrook Dr, Gray, Maine 04039, United States
Country
United States
ID: 24c06cf5-a7dc-42b3-b590-780716cd8047