FDA Inspection
NuPak Medical, LtdNuPak Medical, Ltd – FDA Inspection, Apr 27, 2017
Record Details
This FDA Inspection record concerns NuPak Medical, Ltd, with an inspection on April 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fa986fe6-75f2-42f6-8a63-cfe0a513113f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021889
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of NuPak Medical, Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2024 | Not classified | Dallas District Office |
Other documents for NuPak Medical, Ltd
- FDA Inspection 1245087 - 2024-07-10
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