FDA Inspection
Meditech KFTMeditech KFT – FDA Inspection, Apr 13, 2012
Record Details
This FDA Inspection record concerns Meditech KFT, with an inspection on April 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Meditech KFT
- Inspection Date
- April 13, 2012
- Product Type
- Devices
View Company Profile
ID · cd807e28-e4e5-4cf9-af33-bb2dbe368cac
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 779843
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Meditech KFT
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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