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Filmecc Development Center, Seto, Japan – FDA Inspections

Inspection records and compliance data for Filmecc Development Center in Seto. 1 FDA inspection on record, 1 Form 483, last inspected January 23, 2025.

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Company Profile

This profile covers Filmecc Development Center based in Seto, Japan.

FDA Inspection History

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

Inspected January 23, 2025.

Most cited issue areas

  • Acceptable supplier records, inadequate records1 inspection
  • Design validation- Lack of or inadequate procedures1 inspection
  • Quality audits - Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
January 23, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1259494
FDA documents

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

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Company Information

Name

Filmecc Development Center

FEI Number

3023209233

Address

3-100, Akatsuki-Cho, Seto, Japan

Country

Japan

ID: 12561726-a88a-43af-a644-5bcc27a39f1f

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