FDA Inspection
Peter Lazic GmbhPeter Lazic Gmbh – FDA Inspection, May 18, 2017
Record Details
This FDA Inspection record concerns Peter Lazic Gmbh, with an inspection on May 18, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · aae0e1ee-dd77-43e4-b132-ea9b4cd8e4c5
Inspection Facts
- Inspection number
- 1015933
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Peter Lazic Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2024 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| July 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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