FDA Inspection
Lorenz Lifetech spaLorenz Lifetech spa – FDA Inspection, Jul 30, 2015
Record Details
This FDA Inspection record concerns Lorenz Lifetech spa, with an inspection on July 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lorenz Lifetech spa
- Inspection Date
- July 30, 2015
- Product Type
- Devices
View Company Profile
ID · eba27bc9-a238-4477-8ea0-59cf15487e27
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 938722
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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