FDA Inspection
Lena CupLena Cup – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns Lena Cup, with an inspection on July 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 88454f87-fbc9-4289-a123-9c3b5e91f60a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060464
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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