FDA Inspection
Loewenstein Medical Technology GMBH + CO. KGLoewenstein Medical Technology GMBH + CO. KG – FDA Inspection, Jan 31, 2013
Record Details
This FDA Inspection record concerns Loewenstein Medical Technology GMBH + CO. KG, with an inspection on January 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 31, 2013
- Product Type
- Devices
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ID · 26811bef-e6ea-4114-b873-890870ef5bc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820220
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
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