FDA-Inspected Site

Bluewave Technologies Inc

1 FDA inspection is on record for Bluewave Technologies Inc in Orange City, United States.

483· Form 483 issued

Orange City, United States · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-05-22.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 May 2026 – 22 May 2026Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

22 May 2026
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Brandon P Thompson

22 May 2026
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Brandon P Thompson

22 May 2026
21 CFR 830.300(a)

Devices subject to device identification GUDID data submission requirements.

Cited by Brandon P Thompson

22 May 2026
21 CFR 830.300(a)

Devices subject to device identification GUDID data submission requirements.

Cited by Brandon P Thompson

22 May 2026
ISO 13485:2016 Clause 4.2.4

Lack of document control

Cited by Brandon P Thompson

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations2x
21 CFR 830.300(a)Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 4.2.4Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Bluewave Technologies Inc's 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat