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Aea Srl, Maiolati Spontini, Italy – FDA Inspections

Inspection records and compliance data for Aea Srl in Maiolati Spontini. 2 FDA inspections on record, 1 Form 483, last inspected January 10, 2020.

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Company Profile

This profile covers Aea Srl based in Maiolati Spontini, Italy.

FDA Inspection History

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

First inspected June 15, 2017. Last inspected January 10, 2020.

Most cited issue areas

  • Failure to submit1 inspection
  • Failure to submit, distinct marking1 inspection
  • Lack of or inadequate process validation1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
January 10, 2020NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1116630
June 15, 2017VAIMedical Devices & Rad Health · Radiation Control and Health Safety Act1014903
FDA documents

Form 483s (1)

  • Form 483s · January 10, 2020
People (1)
Stephen D. Eich
Person
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Company Information

Name

Aea Srl

FEI Number

3006571738

Address

Via Monteschiavo 3, De Maiolati, Maiolati Spontini, Italy

Country

Italy

ID: 7e4f0246-4e69-460c-ae03-9110ddcd9883

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