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Shandong Xinhua Pharmaceutical Co Ltd. First Plant — FDA Facility Profile

FEI 3002808153

Shandong Xinhua Pharmaceutical Co Ltd. First Plant is an FDA-registered facility (FEI 3002808153) located in Shandong Province 255075, CN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 4 FDA inspections at this facility.

Facility Details

Location
Shandong Province 255075 (CN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Recent inspections

  • 1220079 (NAI Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000050 (NAI Thu Mar 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875678 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 685447 (NAI Tue Jul 13 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-5335062-6/11/1 (Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BUU-1233351-0/11/1 (Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 109-0920879-4/1/1 (Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 109-0920879-4/1/2 (Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-0099425-4/1/1 (Fri Oct 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • W69-4080230-0/1/1 (Fri Jan 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 820-4572693-0/1/1 (Thu Sep 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 820-4564375-4/2/1 (Fri May 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 820-4563069-4/1/1 (Tue May 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 820-4532939-6/1/1 (Tue Feb 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources