Midwest-Tek, Inc. – FDA Inspection, Apr 1, 2026

Record Details

This FDA Inspection record concerns Midwest-Tek, Inc., with an inspection on April 1, 2026, issued by the Detroit District Office, covering medical devices & rad health.

Company: Midwest-Tek, Inc.
Inspection Date: April 1, 2026
Product Type: Medical Devices & Rad Health
Office: Detroit District Office
Person: Shannon A. Gregory (Investigator)

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

Inspection Facts

Inspection number: 1310382
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 4.2.5Procedures for control of records not documented
ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
ISO 13485:2016 Clause 7.5.1Production controls not adequate
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained

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FDA Inspection

Midwest-Tek, Inc.April 1, 2026