FDA Inspection
KAYSERBETTEN GMBH & CO. KGKAYSERBETTEN GMBH & CO. KG – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns KAYSERBETTEN GMBH & CO. KG, with an inspection on September 24, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- KAYSERBETTEN GMBH & CO. KG
- Inspection Date
- September 24, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 5d51c2cf-2cf1-47e3-a305-875082849544
Inspection Facts
- Inspection number
- 1337222
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 5.6.1QMS not reviewed by top management at documented planned intervals
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
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