Maitland Engineering. Inc. - Inspection Records

Inspection records and compliance data for Maitland Engineering. Inc. in South Bend, Indiana. 3 FDA inspections on record, 1 Form 483, last inspected October 31, 2024.

Company Profile

This profile covers Maitland Engineering. Inc. based in South Bend, Indiana, United States.

FDA Inspection History

FDA inspections: 3
OAI: 0
VAI: 1
NAI: 1
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected September 8, 2017. Last inspected October 31, 2024.

Most cited issue areas

Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
Lack of or inadequate procedures1 inspection
Lack of or inadequate process validation1 inspection

Most recent inspections

Date	Classification	Office	Project area
October 31, 2024	Not classified	Detroit District Office	Compliance: Medical Devices
October 15, 2021	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 8, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices

Documents (6)

FDA Inspection 1253749 - Maitland Engineering. Inc. - 2024-10-31

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483 - Maitland Engineering. Inc. - 2021-10-15

483

FDA Inspection 1155180 - Maitland Engineering. Inc. - 2021-10-15

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FDA Inspection 1155180 - Maitland Engineering. Inc. - 2021-10-15

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FDA Inspection 1025573 - Maitland Engineering. Inc. - 2017-09-08

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FDA Inspection 1025573 - Maitland Engineering. Inc. - 2017-09-08

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