FDA Inspection
General Devices LlcGeneral Devices Llc – FDA Inspection, Jun 11, 2015
Record Details
This FDA Inspection record concerns General Devices Llc, with an inspection on June 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- General Devices Llc
- Inspection Date
- June 11, 2015
- Product Type
- Devices
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ID · 7240be77-4617-4f28-b5b6-ec17e8b25f48
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 931039
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of General Devices Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 29, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for General Devices Llc
- FDA Inspection 1018328 - 2017-03-30
- FDA Inspection 812713 - 2012-12-14
- FDA Inspection 678182 - 2010-07-29
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