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GFA Production Xiamen Co., Ltd. — FDA Facility Profile

FEI 3008384335

GFA Production Xiamen Co., Ltd. is an FDA-registered facility (FEI 3008384335) located in Tong An, Xiamen Fujian, CN. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Tong An, Xiamen Fujian (CN)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1227212 (OAI Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090670 (NAI Fri Apr 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998185 (NAI Thu Dec 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909122 (NAI Fri Nov 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851259 (NAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • FD6-5010319-1/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BFB-0613830-2/11/1 (Mon Oct 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BFB-0613832-8/21/1 (Mon Oct 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9963729-9/182/1 (Wed Jan 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 408-1286699-1/1/9 (Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 408-1286699-1/1/20 (Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 408-1286699-1/1/21 (Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 408-1286699-1/1/22 (Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 408-1286699-1/1/19 (Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 628-0138066-8/1/1 (Wed Sep 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources