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ECTOSENSE NV, Rotselaar, Belgium – FDA Inspections

Inspection records and compliance data for ECTOSENSE NV in Rotselaar. 1 FDA inspection on record, 1 Form 483, last inspected August 31, 2023.

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Company Profile

This profile covers ECTOSENSE NV based in Rotselaar, Belgium.

FDA Inspection History

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

Inspected August 31, 2023.

Most cited issue areas

  • Lack of or inadequate final acceptance procedures1 inspection
  • Nonconforming product, Lack of or inadequate procedures1 inspection
  • Purchasing controls, Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 31, 2023VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1216778
FDA documents

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

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Company Information

Name

ECTOSENSE NV

FEI Number

3015548442

Address

Bosbessenlaan 19a, Rotselaar, Belgium

Country

Belgium

ID: 180d04a7-b0b0-4641-8086-b845a640492d

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