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FDA Inspection
•XPO HEALTH LIMITED•January 23, 2025

XPO HEALTH LIMITED – FDA Inspection, Jan 23, 2025

Record Details

This FDA Inspection record concerns XPO HEALTH LIMITED, with an inspection on January 23, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
XPO HEALTH LIMITED
Inspection Date
January 23, 2025
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Ellen J. Tave (Issuing Officer)
View Company Profile

ID · c0773da1-1952-482b-8979-ca973e10ae13

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1258923
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities

Full citation text and observation details available on the Dashboard.

Other FDA inspections of XPO HEALTH LIMITED

1
DateClassificationOfficeProject area
March 19, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for XPO HEALTH LIMITED
  • FDA Inspection 923676 - 2015-03-19

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