FDA Inspection
Alung Technologies IncAlung Technologies Inc – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns Alung Technologies Inc, with an inspection on March 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6ceb5ae-fb2a-40d5-acd7-7e66457cb754
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016272
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Alung Technologies Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alung Technologies Inc
- FDA Inspection 1088940 - 2019-04-03
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