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Laboratorio Reig Jofre S.A., Toledo, Spain – FDA Inspections

Inspection records and compliance data for Laboratorio Reig Jofre S.A. in Toledo. 4 FDA inspections on record (2 OAI), 2 Form 483s, last inspected June 23, 2023.

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Company Profile

This profile covers Laboratorio Reig Jofre S.A. based in Toledo, Spain.

FDA Inspection History

FDA inspections
4
OAI
2
VAI
1
NAI
0
Unclassified
1
Form 483s
2
Warning letters
0

First inspected July 31, 2013. Last inspected June 23, 2023.

Most cited issue areas

  • Procedures for sterile drug products2 inspections
  • Procedures not in writing, fully followed2 inspections
  • Complete test data included in records1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
June 23, 2023OAIHuman Drugs · Drug Quality Assurance1208633
June 14, 2019Not classifiedHuman Drugs · Generic Drug Evaluation1094577
July 14, 2015OAIHuman Drugs · Drug Quality Assurance937537
July 31, 2013VAIHuman Drugs · Drug Quality Assurance846291
FDA documents

Form 483s (2)

  • Form 483s · June 23, 2023
  • Form 483s · June 14, 2019
People (4)
Junho Pak
Person
Darren S. Brown
Person
Xiaokuang Lai
Person
Pratik S. Upadhyay
Person
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Company Information

Name

Laboratorio Reig Jofre S.A.

FEI Number

3009713694

Address

Poligono Industrial, Calle Jarama 111, Toledo, Spain

Country

Spain

ID: a6b83a70-2bd5-4cc1-8007-61357916a14f

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