FDA Inspection
Walz Elektronik GmbhWalz Elektronik Gmbh – FDA Inspection, Sep 10, 2026
Record Details
This FDA Inspection record concerns Walz Elektronik Gmbh, with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Walz Elektronik Gmbh
- Inspection Date
- September 10, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 77355d44-af8d-4fce-a31a-9a46409b1dfc
Inspection Facts
- Inspection number
- 1335100
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.35(a)Lack of justification for not investigating complaints requiring investigation
- 21 CFR 820.35(c)UDI was not recorded for each medical device or batch
- ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
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