FDA Inspection 1311588 - IVIMEA LLC - March 31, 2026

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Record Details

This FDA Inspection record concerns IVIMEA LLC, with an inspection on March 31, 2026, issued by the New Jersey District Office, covering medical devices & rad health.

Company: IVIMEA LLC
Inspection Date: March 31, 2026
Product Type: Medical Devices & Rad Health
Office: New Jersey District Office

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ID · 504b486a-fd2e-4a6f-8545-c2f9d9e80f5c

Violation Codes10

21 CFR 1002.1021 CFR 1002.1321 CFR 1010.2(c)21 CFR 1040.10(g)(3)21 CFR 1040.11(a)(3)21 CFR 803.1721 CFR 830.310(b)ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 4.2.5ISO 13485:2016 Clause 5.6.1

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