FDA Inspection
Neways Leeuwarden B.V.Neways Leeuwarden B.V. – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Neways Leeuwarden B.V., with an inspection on August 30, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
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ID · 757c35f1-252a-4b0e-9fbe-56deaf088ec2
Inspection Facts
- Inspection number
- 1101660
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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