FDA Inspection
Elos Medtech Timmersdala ABElos Medtech Timmersdala AB – FDA Inspection, Oct 14, 2010
Record Details
This FDA Inspection record concerns Elos Medtech Timmersdala AB, with an inspection on October 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elos Medtech Timmersdala AB
- Inspection Date
- October 14, 2010
- Product Type
- Devices
View Company Profile
ID · ad9641a6-63f5-4e09-8c31-3c4a501156e9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 698517
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - 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
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Other FDA inspections of Elos Medtech Timmersdala AB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2025 | NAI | Compliance: Devices | |
| May 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elos Medtech Timmersdala AB
- FDA Inspection 1282412 - 2025-08-21
- FDA Inspection 837222 - 2013-05-29
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