FDA Inspection
MALSCH GMBHMALSCH GMBH – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns MALSCH GMBH, with an inspection on September 3, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · a8501621-9b43-4799-9fcb-f6dddc96199c
Inspection Facts
- Inspection number
- 1334166
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
- ISO 13485:2016 Clause 7.4.1Supplier evaluation and selection criteria do not include required elements
- ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MALSCH GMBH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MALSCH GMBH
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.