FDA inspection

SMITH AND NEPHEW OPERATIONS SDN. BHD: FDA inspection ending Feb 8, 2024

FDA inspection 1232963 · No Action Indicated (NAI) · Penang

Key facts

Inspection ID 1232963
Firm SMITH AND NEPHEW OPERATIONS SDN. BHD
FEI number 3022142628
Address Pmt 797, Persiaran Cassia Selatan 8, Taman Perindustrian Batu Kawan, Bandar Cassia
City Penang
Fiscal year 2024
Inspection end date Feb 8, 2024
Classification No Action Indicated (NAI)
Project area 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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