Advanced Image Enhancement, Inc., Fall River, MA – FDA Inspections

Inspection records and compliance data for Advanced Image Enhancement, Inc. in Fall River, Massachusetts. 4 FDA inspections on record, last inspected March 20, 2024.

Company Profile

This profile covers Advanced Image Enhancement, Inc. based in Fall River, Massachusetts, United States.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 2
NAI: 2
Form 483s: 0
Warning letters: 0

First inspected March 26, 2010. Last inspected March 20, 2024.

Most cited issue areas

Design changes - Lack of or Inadequate Procedures1 inspection
Design validation- Lack of or inadequate procedures1 inspection
Design validation - software validation not performed1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
March 20, 2024	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1236885
March 1, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	820903
February 1, 2011	VAI	Medical Devices & Rad Health · Compliance: Devices	706763
March 26, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	654085

FDA documents

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

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