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FDA Inspection
•BrightGene Fine Chemical Co., Ltd (Tongyuan Road)•January 20, 2024

BrightGene Fine Chemical Co., Ltd (Tongyuan Road) – FDA Inspection, Jan 20, 2024

Record Details

This FDA Inspection record concerns BrightGene Fine Chemical Co., Ltd (Tongyuan Road), with an inspection on January 20, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
BrightGene Fine Chemical Co., Ltd (Tongyuan Road)
Inspection Date
January 20, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Kellia N. Hicks (FDA Associated Person)
View Company Profile

ID · c26b4ad6-a569-416c-a916-5249e4e99e0a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1228291
FDA center
Human Drugs
Project area
Drug Quality Assurance

Other FDA inspections of BrightGene Fine Chemical Co., Ltd (Tongyuan Road)

2
DateClassificationOfficeProject area
May 31, 2019Not classifiedOffice of Inspections and Investigations
September 25, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for BrightGene Fine Chemical Co., Ltd (Tongyuan Road)
  • FDA Inspection 1095515 - 2019-05-31
  • FDA Inspection 945682 - 2015-09-25

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