FDA inspection

Empirical Spine, Inc.: FDA inspection ending Sep 11, 2024

FDA inspection 1251259 · No Action Indicated (NAI) · Morgan Hill, California

Key facts

Inspection ID 1251259
Firm Empirical Spine, Inc.
FEI number 3013114075
Address 18655 Madrone Pkwy Ste 180
City Morgan Hill
State California
ZIP 95037
Fiscal year 2024
Inspection end date Sep 11, 2024
Classification No Action Indicated (NAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None 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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