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FDA Inspection
•Eagle Electric (Shenzhen) Co., LTD.•October 12, 2017

Eagle Electric (Shenzhen) Co., LTD. – FDA Inspection, Oct 12, 2017

Record Details

This FDA Inspection record concerns Eagle Electric (Shenzhen) Co., LTD., with an inspection on October 12, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Eagle Electric (Shenzhen) Co., LTD.
Inspection Date
October 12, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Andrea A. Branche (FDA Associated Person)
View Company Profile

ID · a2521010-d433-4ada-a90f-81a54d338a86

Inspection Facts

Inspection number
1029454
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Eagle Electric (Shenzhen) Co., LTD.

3
DateClassificationOfficeProject area
May 8, 2026Not classifiedOffice of Inspections and Investigations
November 2, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
April 23, 2015NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Eagle Electric (Shenzhen) Co., LTD.
  • FDA Inspection 1308004 - 2026-05-08
  • FDA Inspection 1224302 - 2023-11-02
  • FDA Inspection 928634 - 2015-04-23

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