FDA Inspection
Uberlube, Inc.Uberlube, Inc. – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Uberlube, Inc., with an inspection on March 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Emma R. Schaefer (Issuing Officer)
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ID · c677c4f7-42f9-4af8-b0ad-fcb1fd2b8f20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084381
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Uberlube, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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