FDA Inspection
A&D Company Manufacturing, Ltd.A&D Company Manufacturing, Ltd. – FDA Inspection, Mar 17, 2023
Record Details
This FDA Inspection record concerns A&D Company Manufacturing, Ltd., with an inspection on March 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · efbd1cb8-37f4-4e09-9c5e-d0f4a314332a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200951
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(c)Investigation of device failures
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Other FDA inspections of A&D Company Manufacturing, Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for A&D Company Manufacturing, Ltd.
- FDA Inspection 1061532 - 2018-06-21
- FDA Inspection 988304 - 2016-07-22
- FDA Inspection 885554 - 2014-06-06
- FDA Inspection 574101 - 2009-02-19
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