FDA Inspection
Availmed SA de CVAvailmed SA de CV – FDA Inspection, Mar 15, 2018
Record Details
This FDA Inspection record concerns Availmed SA de CV, with an inspection on March 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fe71cf85-502b-4016-9142-297c438c1d11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044794
- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Availmed SA de CV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 20, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Availmed SA de CV
- FDA Inspection 1047059 - 2016-10-20
- FDA Inspection 994789 - 2016-10-20
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