Company
United StatesOrthoFundamentals, Llc, Waltham, MA – FDA Inspections
Inspection records and compliance data for OrthoFundamentals, Llc in Waltham, Massachusetts. 1 FDA inspection on record, 1 Form 483, last inspected May 20, 2025.
Company Profile
This profile covers OrthoFundamentals, Llc based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected May 20, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 20, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1271579 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
OrthoFundamentals, Llc
FEI Number
3024124172
Address
303 Wyman St Ste 300, Waltham, Massachusetts 02451, United States
Country
United States
ID: 9cd46ea6-5f72-429a-a7b0-06218aec4653