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FDA Inspection
•Qilu Pharmaceutical Co., Ltd.•February 22, 2019

Qilu Pharmaceutical Co., Ltd. – FDA Inspection, Feb 22, 2019

Record Details

This FDA Inspection record concerns Qilu Pharmaceutical Co., Ltd., with an inspection on February 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Qilu Pharmaceutical Co., Ltd.
Inspection Date
February 22, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Marcellinus D. Dordunoo (FDA Associated Person)
View Company Profile

ID · 34945e69-b9f9-4aaf-8d2b-90f401ee3bf2

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1088395
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Qilu Pharmaceutical Co., Ltd.

5
DateClassificationOfficeProject area
April 4, 2025Not classifiedOffice of Inspections and Investigations
March 9, 2018NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 23, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 25, 2013NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 1, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Qilu Pharmaceutical Co., Ltd.
  • FDA Inspection 1269032 - 2025-04-04
  • FDA Inspection 1048729 - 2018-03-09
  • FDA Inspection 989208 - 2016-09-23
  • FDA Inspection 855751 - 2013-10-25
  • FDA Inspection 674203 - 2010-07-01

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