Turtle Shell Technologies Private Limited – FDA Inspection, Sep 17, 2026

Record Details

This FDA Inspection record concerns Turtle Shell Technologies Private Limited, with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Turtle Shell Technologies Private Limited
Inspection Date: September 17, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Felix J. Marrero (Issuing Officer)

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ID · 4e7245c8-5f58-42ac-878e-0f8d158e4197

Inspection Facts

Inspection number: 1336012
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 6.1(a)Resources for quality management system have not been determined or provided

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FDA Inspection

Turtle Shell Technologies Private LimitedSeptember 17, 2026