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Tedec-Meiji Farma, S.A., Alcala de Henares, Spain – FDA Inspections

Inspection records and compliance data for Tedec-Meiji Farma, S.A. in Alcala de Henares. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected December 15, 2016.

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Company Profile

This profile covers Tedec-Meiji Farma, S.A. based in Alcala de Henares, Spain.

FDA Inspection History

FDA inspections
4
OAI
1
VAI
3
NAI
0
Form 483s
1
Warning letters
0

First inspected July 22, 2011. Last inspected December 15, 2016.

Most cited issue areas

  • Procedures not in writing, fully followed2 inspections
  • Complaint Handling Procedure1 inspection
  • Complete test data included in records1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
December 15, 2016VAIMedical Devices & Rad Health · Bioresearch Monitoring996370
December 12, 2014VAIHuman Drugs · Drug Quality Assurance908026
November 22, 2012VAIHuman Drugs · Drug Quality Assurance809541
July 22, 2011OAIHuman Drugs · Drug Quality Assurance741672
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Company Information

Name

Tedec-Meiji Farma, S.A.

FEI Number

3003184440

Address

Carretera M-300 Km 30. 500, Alcala de Henares, Spain

Country

Spain

ID: 8cd12cc2-f101-46d8-b715-8ff0b37fb759

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