FDA inspection

Black Forest Medical North America Inc: FDA inspection ending Feb 15, 2023

FDA inspection 1198065 · Voluntary Action Indicated (VAI) · Cape Coral, FL

Key facts

Inspection ID 1198065
Firm Black Forest Medical North America Inc
FEI number 3003923579
Address 4529 SE 16th Pl Ste 101
City Cape Coral
State FL
ZIP 33904
Country United States
Fiscal year 2023
Inspection end date Feb 15, 2023
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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