FDA Inspection
Institut Virion/Serion GmbhInstitut Virion/Serion Gmbh – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Institut Virion/Serion Gmbh, with an inspection on September 13, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Institut Virion/Serion Gmbh
- Inspection Date
- September 13, 2018
- Product Type
- Medical Devices & Rad Health
- Person
- Lisa A. Stura (Issuing Officer)
View Company Profile
ID · 4841a889-49a7-4ae3-be04-d4b8c60164fb
Inspection Facts
- Inspection number
- 1065778
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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