FDA Inspection 1301490 - CAREstream Medical Ltd - February 06, 2026

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Record Details

This FDA Inspection record concerns CAREstream Medical Ltd, with an inspection on February 6, 2026, covering devices.

Company: CAREstream Medical Ltd
Inspection Date: February 6, 2026
Product Type: Devices

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ID · 36935a69-1e0d-4e2a-a24b-1ee0448e573e

Violation Codes6

21 CFR 801.20(a)ISO 13485:2016 Clause 4.1.1ISO 13485:2016 Clause 7.3.1ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.2.2

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