FDA Inspection
Uberlube, Inc.Uberlube, Inc. – FDA Inspection, Feb 16, 2023
Record Details
This FDA Inspection record concerns Uberlube, Inc., with an inspection on February 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a4c797c7-fa5c-4ffe-a70d-0d6e19e11b51
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1197626
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 806.20(a)Records not kept
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Uberlube, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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