Company
MalaysiaSupercomal Medical Products, Sdn Bhd, Sungai Petani, Malaysia – FDA Inspections
Inspection records and compliance data for Supercomal Medical Products, Sdn Bhd in Sungai Petani. 2 FDA inspections on record, 2 Form 483s, last inspected August 03, 2023.
Company Profile
This profile covers Supercomal Medical Products, Sdn Bhd based in Sungai Petani, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected May 4, 2017. Last inspected August 3, 2023.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Equipment control activity documentation1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 3, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1215637 |
| May 4, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1017158 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Supercomal Medical Products, Sdn Bhd
FEI Number
3004832480
Address
Lot 172, Jalan Pknk 3/8; Kedah D.A., Sungai Petani, Malaysia
Country
Malaysia
ID: 469a412c-9e0a-4609-ad34-63bcd699290b