FDA Inspection
BEKA Hospitec GmbhBEKA Hospitec Gmbh – FDA Inspection, Feb 2, 2017
Record Details
This FDA Inspection record concerns BEKA Hospitec Gmbh, with an inspection on February 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 77ed762b-461b-4422-b109-21ed18a04deb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002323
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.184DHR content
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