FDA Inspection
Harmar Mobility, LLC.Harmar Mobility, LLC. – FDA Inspection, Jun 26, 2009
Record Details
This FDA Inspection record concerns Harmar Mobility, LLC., with an inspection on June 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Harmar Mobility, LLC.
- Inspection Date
- June 26, 2009
- Product Type
- Devices
View Company Profile
ID · 03c80656-aa19-458a-991d-fe1ef0be1af0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 592440
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.184(d)Acceptance records
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Other FDA inspections of Harmar Mobility, LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | Not classified | Kansas City District Office | |
| July 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Harmar Mobility, LLC.
- FDA Inspection 1302712 - 2026-02-06
- FDA Inspection 1174546 - 2022-07-15
- FDA Inspection 1071533 - 2018-11-13
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