FDA Inspection
Alltech Medical Systems America IncAlltech Medical Systems America Inc – FDA Inspection, Jul 29, 2019
Record Details
This FDA Inspection record concerns Alltech Medical Systems America Inc, with an inspection on July 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fb8f768c-8952-4941-a9bb-d188ba4eb700
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097831
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Alltech Medical Systems America Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Alltech Medical Systems America Inc
- FDA Inspection 827215 - 2013-03-21
- FDA Inspection 589973 - 2009-06-17
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