Company
United StatesDenterprise International, Inc., Ormond Beach, FL – FDA Inspections
Inspection records and compliance data for Denterprise International, Inc. in Ormond Beach, Florida. 4 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected August 19, 2021.
Company Profile
This profile covers Denterprise International, Inc. based in Ormond Beach, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 1
First inspected July 29, 2016. Last inspected August 19, 2021.
Most cited issue areas
- Lack of or inadequate DHR procedures3 inspections
- Lack of or inadequate procedures - Acceptance activities3 inspections
- Purchasing controls, Lack of or inadequate procedures3 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 19, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1149181 |
| May 6, 2019 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1090180 |
| March 12, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1044362 |
| July 29, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 982613 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Denterprise International, Inc.
FEI Number
1000113729
Address
156 E Granada Blvd, Ormond Beach, Florida 32176, United States
Country
United States
ID: ce1ada61-2b45-4025-9110-1c3eee71b376