FDA Inspection
Labotect Labor-Technik Gottingen GmbHLabotect Labor-Technik Gottingen GmbH – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns Labotect Labor-Technik Gottingen GmbH, with an inspection on June 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c9daff60-8c99-4197-b7d3-5bb7e0619e2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055546
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.184DHR content
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