FDA Inspection
WALDEMAR LINK GMBH & CO. KGWALDEMAR LINK GMBH & CO. KG – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns WALDEMAR LINK GMBH & CO. KG, with an inspection on August 22, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- WALDEMAR LINK GMBH & CO. KG
- Inspection Date
- August 22, 2019
- Product Type
- Medical Devices & Rad Health
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ID · ec7c968a-22d8-4fb1-8eda-e45ad5d49eb0
Inspection Facts
- Inspection number
- 1100417
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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