SpectraWAVE, Inc. – FDA Inspection, Aug 11, 2026

Record Details

This FDA Inspection record concerns SpectraWAVE, Inc., with an inspection on August 11, 2026, issued by the New England District Office, covering medical devices & rad health.

Company: SpectraWAVE, Inc.
Inspection Date: August 11, 2026
Product Type: Medical Devices & Rad Health
Office: New England District Office
Person: James P. Finn (Company Rep)

View Company Profile

ID · bf040e20-f5df-48e9-935a-b6ec29f291c8

Inspection Facts

Inspection number: 1330484
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act
Outcome: Form 483 issued

FDA Citations

21 CFR 1002.10Failure to submit, distinct marking
21 CFR 803.17Lack of Written MDR Procedures
ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore SpectraWAVE, Inc.

FDA Inspection

SpectraWAVE, Inc.August 11, 2026