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FDA Inspection
•Zhuhai United Laboratories Co. Ltd.•July 16, 2019

Zhuhai United Laboratories Co. Ltd. – FDA Inspection, Jul 16, 2019

Record Details

This FDA Inspection record concerns Zhuhai United Laboratories Co. Ltd., with an inspection on July 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Zhuhai United Laboratories Co. Ltd.
Inspection Date
July 16, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Raquel Gonzalez Rivera (FDA Associated Person)
  • Rumany C. Penn (FDA Associated Person)
  • Vincent Thomas (Issuing Officer)
View Company Profile

ID · 89cea060-20d2-492e-aa44-e0ff48e0b7a9

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1098866
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Zhuhai United Laboratories Co. Ltd.

6
DateClassificationOfficeProject area
September 18, 2026Not classifiedOffice of Inspections and Investigations
August 3, 2023OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 15, 2017OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 31, 2015OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 23, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for Zhuhai United Laboratories Co. Ltd.
  • FDA Inspection 1343444 - 2026-09-18
  • FDA Inspection 1215530 - 2023-08-03
  • FDA Inspection 1029448 - 2017-09-15
  • FDA Inspection 929653 - 2015-03-31
  • FDA Inspection 815793 - 2012-10-23

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