FDA Inspection
Light-Tech, Inc.Light-Tech, Inc. – FDA Inspection, Aug 9, 2011
Record Details
This FDA Inspection record concerns Light-Tech, Inc., with an inspection on August 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Light-Tech, Inc.
- Inspection Date
- August 9, 2011
- Product Type
- Devices
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ID · bcbda156-ae75-4ae4-a025-2297b790b0d2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 738552
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Light-Tech, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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