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FDA inspection

Isomedix Operations Inc: FDA inspection ending Mar 12, 2026

FDA inspection 1310210 · No Action Indicated (NAI) · Spartanburg, South Carolina

Key facts

Inspection ID 1310210
Firm Isomedix Operations Inc
FEI number 1047843
Address 2072 Southport Rd
City Spartanburg
State South Carolina
ZIP 29306
Fiscal year 2026
Inspection end date Mar 12, 2026
Classification No Action Indicated (NAI)
Project area Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: Devices|Project Evaluation: 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
  • 10–99 Inspections at this FEI

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

Other inspections at this establishment

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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