FDA Inspection
Supercomal Medical Products, Sdn BhdSupercomal Medical Products, Sdn Bhd – FDA Inspection, Aug 3, 2023
Record Details
This FDA Inspection record concerns Supercomal Medical Products, Sdn Bhd, with an inspection on August 3, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 59d00acb-dfd1-4447-b232-8e506f250eb4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215637
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment control activity documentation
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Other FDA inspections of Supercomal Medical Products, Sdn Bhd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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