FDA Inspection
Berlin Heart IncBerlin Heart Inc – FDA Inspection, Jul 2, 2025
Record Details
This FDA Inspection record concerns Berlin Heart Inc, with an inspection on July 2, 2025, issued by the Dallas District Office, covering medical devices & rad health.
View Company Profile
ID · 92acc067-bf3f-4e68-bba7-f75a7f5d6364
Inspection Facts
- Inspection number
- 1274495
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
2- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Berlin Heart Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Berlin Heart Inc
- FDA Inspection 999932 - 2016-12-09
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.