FDA Inspection
Electric Mobility CorpElectric Mobility Corp – FDA Inspection, Nov 16, 2010
Record Details
This FDA Inspection record concerns Electric Mobility Corp, with an inspection on November 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Electric Mobility Corp
- Inspection Date
- November 16, 2010
- Product Type
- Devices
View Company Profile
ID · d13f25c6-1905-4f28-8c8d-05593232110c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 685708
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Electric Mobility Corp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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