INDIUS Medical Technologies Pvt. Ltd. – FDA Inspection, Sep 24, 2026

Record Details

This FDA Inspection record concerns INDIUS Medical Technologies Pvt. Ltd., with an inspection on September 24, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: INDIUS Medical Technologies Pvt. Ltd.
Inspection Date: September 24, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Felix J. Marrero (Issuing Officer)

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ID · 772b3072-b5b4-440b-abcb-ded790338807

Inspection Facts

Inspection number: 1338544
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 801.20(a)Label to bear a unique device identifier
21 CFR 803.17Lack of Written MDR Procedures
ISO 13485:2016 Clause 6.1(a)Resources for quality management system have not been determined or provided
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented

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FDA Inspection

INDIUS Medical Technologies Pvt. Ltd.September 24, 2026