FDA Inspection 1181678 - BERLIN HEART GMBH - October 13, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore BERLIN HEART GMBH

Record Details

This FDA Inspection record concerns BERLIN HEART GMBH, with an inspection on October 13, 2022, issued by the Center for Devices and Radiological Health, covering devices.

Company: BERLIN HEART GMBH
Inspection Date: October 13, 2022
Product Type: Devices
Office: Center for Devices and Radiological Health

Open in Dashboard

ID · be9d11c2-c423-40d4-9525-3c7c24446430

Violation Codes6

21 CFR 803.17(a)(2)21 CFR 806.10(a)(1)21 CFR 820.100(a)21 CFR 820.18421 CFR 820.30(c)21 CFR 820.30(d)

Full citation text and observation details available on the Dashboard.