FDA Inspection
ABA Medical Technology Co LtdABA Medical Technology Co Ltd – FDA Inspection, May 25, 2017
Record Details
This FDA Inspection record concerns ABA Medical Technology Co Ltd, with an inspection on May 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e39a25d9-f656-413f-9036-ae7bcf74ad08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014696
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of ABA Medical Technology Co Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ABA Medical Technology Co Ltd
- FDA Inspection 896538 - 2014-08-21
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