FDA Inspection 1310382 - Midwest-Tek, Inc. - April 01, 2026

FDA Inspection 1310382 for Midwest-Tek, Inc. on April 01, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1310382 for Midwest-Tek, Inc. on April 01, 2026. Classification: N/A.

Violation Codes

ISO 13485:2016 Clause 4.2.5

ISO 13485:2016 Clause 7.3.9

ISO 13485:2016 Clause 7.5.1

ISO 13485:2016 Clause 7.5.6

ISO 13485:2016 Clause 8.3.1

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Record Information

Company

Midwest-Tek, Inc.

Inspection Date

April 1, 2026

Product Type

Medical Devices & Rad Health

Office

Detroit District Office

ID: fed62291-3630-476e-98ac-ffbadebda5d3

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