FDA Inspection 1314952 - PureWave Life LLC - April 29, 2026

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Record Details

This FDA Inspection record concerns PureWave Life LLC, with an inspection on April 29, 2026, issued by the Florida District Office, covering medical devices & rad health.

Company: PureWave Life LLC
Inspection Date: April 29, 2026
Product Type: Medical Devices & Rad Health
Office: Florida District Office

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ID · b78c43f9-047b-4931-84d1-cf595ca1f27b

Violation Codes7

21 CFR 801.20(a)21 CFR 803.1721 CFR 830.300(a)ISO 13485:2016 Clause 4.1.5ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 7.3.2ISO 13485:2016 Clause 8.2.4

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