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BIOTEC ITALIA, Dueville, Italy – FDA Inspections

Inspection records and compliance data for BIOTEC ITALIA in Dueville. 1 FDA inspection on record, last inspected August 08, 2024.

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Company Profile

This profile covers BIOTEC ITALIA based in Dueville, Italy.

FDA Inspection History

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

Inspected August 8, 2024.

Most cited issue areas

  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 8, 2024VAIMedical Devices & Rad Health · Compliance: Devices1249530
FDA documents

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

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ET Medical Devices S.p.A.
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Company Information

Name

BIOTEC ITALIA

FEI Number

3010627091

Address

Via Della Repubblica 20, Dueville, Italy

Country

Italy

ID: 88fdec83-d1c2-48ad-bf60-a1c9f6c6881b

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