Company
United StatesBonafix Surgical and Dental Implants, LLC, Delray Beach, FL – FDA Inspections
Inspection records and compliance data for Bonafix Surgical and Dental Implants, LLC in Delray Beach, Florida. 2 FDA inspections on record, 1 Form 483, last inspected March 11, 2019.
Company Profile
This profile covers Bonafix Surgical and Dental Implants, LLC based in Delray Beach, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 27, 2015. Last inspected March 11, 2019.
Most cited issue areas
- Design validation - production units1 inspection
- Evaluation and Selection, Suppliers, Contractors, etc.1 inspection
- Review and evaluation for investigation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 11, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1082391 |
| February 27, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 916489 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bonafix Surgical and Dental Implants, LLC
FEI Number
3009829584
Address
160 Congress Park Dr Ste 109, Delray Beach, Florida 33445, United States
Country
United States
ID: 261c3726-5119-4270-bfc0-561b43cb2716