FDA Inspection
Supercomal Medical Products, Sdn BhdSupercomal Medical Products, Sdn Bhd – FDA Inspection, May 4, 2017
Record Details
This FDA Inspection record concerns Supercomal Medical Products, Sdn Bhd, with an inspection on May 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Matthew R. Mcnew (Issuing Officer)
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ID · 51e13a4c-8ba9-40c3-beaa-8f56354ce5d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017158
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.184Lack of or inadequate DHR procedures
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Other FDA inspections of Supercomal Medical Products, Sdn Bhd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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