FDA Inspection
Generic Medical Devices, Inc.FDA Inspection 680230 - Generic Medical Devices, Inc. - September 09, 2010
Record Details
This FDA Inspection record concerns Generic Medical Devices, Inc., with an inspection on September 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 9, 2010
- Product Type
- Devices
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ID · edc22a28-b951-456a-beca-8eda6bbae107
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680230
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Generic Medical Devices, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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