Company
MalaysiaOrtho Solutions Sdn. Bhd., Prai, Malaysia – FDA Inspections
Inspection records and compliance data for Ortho Solutions Sdn. Bhd. in Prai. 1 FDA inspection on record, last inspected May 16, 2024.
Company Profile
This profile covers Ortho Solutions Sdn. Bhd. based in Prai, Malaysia.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected May 16, 2024.
Most cited issue areas
- DHR content1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 16, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1240298 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ortho Solutions Sdn. Bhd.
FEI Number
3012755988
Address
2821, Tingkat Perusahaan 5a, Prai Industrial Estate, Prai, Malaysia
Country
Malaysia
ID: 13ea0613-79dd-487c-b814-b83310bdf8a8