FDA Inspection
KLS Martin SE & Co. KGKLS Martin SE & Co. KG – FDA Inspection, Sep 28, 2011
Record Details
This FDA Inspection record concerns KLS Martin SE & Co. KG, with an inspection on September 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- KLS Martin SE & Co. KG
- Inspection Date
- September 28, 2011
- Product Type
- Devices
View Company Profile
ID · d2799d74-6d3c-4cb8-9d60-c84baf561fd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750308
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of KLS Martin SE & Co. KG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2025 | Not classified | Office of Inspections and Investigations | |
| August 23, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for KLS Martin SE & Co. KG
- FDA Inspection 1258115 - 2025-04-09
- FDA Inspection 1067685 - 2018-08-23
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