FDA Inspection 592440 — Harmar Mobility, LLC.
The FDA completed an inspection of Harmar Mobility, LLC. on June 26, 2009 in Raymore, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Raymore, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |