PureWave Life LLC, Boynton Beach, FL – FDA Inspections

Inspection records and compliance data for PureWave Life LLC in Boynton Beach, FL. 1 FDA inspection on record, 1 Form 483, last inspected April 29, 2026.

Company Profile

This profile covers PureWave Life LLC based in Boynton Beach, FL, United States.

FDA Inspection History

FDA inspections: 1
OAI: 0
VAI: 1
NAI: 0
Form 483s: 1
Warning letters: 0

Inspected April 29, 2026.

Most cited issue areas

Design and development planning documentation not adequate1 inspection
Devices subject to device identification GUDID data submission requirements.1 inspection
External party controls do not include written quality agreements1 inspection

FDA inspections (1)

Date	Result	FDA center(s)	Insp. #
April 29, 2026	VAI	Medical Devices & Rad Health · Compliance: Devices	1314952

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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