Company
United StatesImpactOrtho Inc Hawaii, Honolulu, HI – FDA Inspections
Inspection records and compliance data for ImpactOrtho Inc Hawaii in Honolulu, Hawaii. 1 FDA inspection on record, 1 Form 483, last inspected February 28, 2019.
Company Profile
This profile covers ImpactOrtho Inc Hawaii based in Honolulu, Hawaii, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected February 28, 2019.
Most cited issue areas
- All core requirements covered in program1 inspection
- Contamination, mix ups, improper release1 inspection
- Procedures to meet core CTGP1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 28, 2019 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1080781 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ImpactOrtho Inc Hawaii
FEI Number
3014328922
Address
770 Kapiolani Blvd Ste 615, Honolulu, Hawaii 96813, United States
Country
United States
ID: 5ad1174a-8c89-4370-9957-70bdb79b31a6