FDA Inspection
Alpha ProTech Inc.Alpha ProTech Inc. – FDA Inspection, May 11, 2023
Record Details
This FDA Inspection record concerns Alpha ProTech Inc., with an inspection on May 11, 2023, issued by the Denver District Office.
- Company
- Alpha ProTech Inc.
- Inspection Date
- May 11, 2023
View Company Profile
ID · 9ede31ee-b664-4c35-9b51-b6a33e9a701c
Inspection Facts
- Inspection number
- 1204985
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Alpha ProTech Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alpha ProTech Inc.
- FDA Inspection 1147003 - 2021-07-22
- FDA Inspection 997730 - 2017-01-09
- FDA Inspection 714325 - 2011-03-02
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