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FDA Inspection
•Rechon Life Science AB•September 6, 2024

Rechon Life Science AB – FDA Inspection, Sep 6, 2024

Record Details

This FDA Inspection record concerns Rechon Life Science AB, with an inspection on September 6, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Rechon Life Science AB
Inspection Date
September 6, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Amir Alavi (Company Rep)
  • Amir Hakak
  • Jose E. Melendez (FDA Associated Person)
View Company Profile

ID · 7eaa39d1-9842-4349-8abf-b9462415216b

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1251480
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

Other FDA inspections of Rechon Life Science AB

7
DateClassificationOfficeProject area
March 17, 2023Not classifiedOffice of Inspections and Investigations
November 27, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 29, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 2, 2016NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
April 29, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Rechon Life Science AB
  • FDA Inspection 1201600 - 2023-03-17
  • FDA Inspection 1125627 - 2019-11-27
  • FDA Inspection 1060687 - 2018-06-29
  • FDA Inspection 983550 - 2016-06-02
  • FDA Inspection 969057 - 2016-04-29

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