FDA Inspection
PureWave Life LLCPureWave Life LLC – FDA Inspection, Apr 29, 2026
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.
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ID · b78c43f9-047b-4931-84d1-cf595ca1f27b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1314952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 7.3.2Design and development planning documentation not adequate
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
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