FDA Inspection 1311588 - IVIMEA LLC - March 31, 2026

FDA Inspection 1311588 for IVIMEA LLC on March 31, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1311588 for IVIMEA LLC on March 31, 2026. Classification: N/A.

Violation Codes

21 CFR 1002.10

21 CFR 1002.13

21 CFR 1010.2(c)

21 CFR 1040.10(g)(3)

21 CFR 1040.11(a)(3)

21 CFR 803.17

21 CFR 830.310(b)

ISO 13485:2016 Clause 4.1.2

ISO 13485:2016 Clause 4.2.5

ISO 13485:2016 Clause 5.6.1

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Record Information

Company

IVIMEA LLC

Inspection Date

March 31, 2026

Product Type

Medical Devices & Rad Health

Office

New Jersey District Office

ID: 2431922a-d62a-4bab-bfe2-f4ab19f599ed

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