FDA Inspection 1309260 - Biometerplususa Inc. - March 25, 2026

FDA Inspection 1309260 for Biometerplususa Inc. on March 25, 2026. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1309260 for Biometerplususa Inc. on March 25, 2026. Classification: Voluntary Action Indicated (VAI).

Violation Codes

ISO 13485:2016 Clause 4.1.2

ISO 13485:2016 Clause 4.1.3

ISO 13485:2016 Clause 4.1.5

ISO 13485:2016 Clause 7.5.8

ISO 13485:2016 Clause 7.6(a)

ISO 13485:2016 Clause 8.2.2

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Record Information

Company

Biometerplususa Inc.

Inspection Date

March 25, 2026

Product Type

Devices

ID: f82e4392-7871-4da1-b69b-1943b05bb41b

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