Tec Com Gmbh – FDA Inspection, Aug 23, 2018

Record Details

This FDA Inspection record concerns Tec Com Gmbh, with an inspection on August 23, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Tec Com Gmbh
Inspection Date: August 23, 2018
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Eric M. Padgett (FDA Associated Person)

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ID · 268fc5ae-3580-47cf-beab-4eac41e2f5ee

Inspection Facts

Inspection number: 1063459
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.250(b)Sampling plans

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FDA Inspection

Tec Com GmbhAugust 23, 2018