Criticare Technologies, Inc.June 11, 2018

FDA 483 - Criticare Technologies, Inc. - June 11, 2018

View on Dashboard

Discuss this record with AI

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 Criticare Technologies, Inc.

Record Details

Criticare Technologies Inc. in North Kingstown, RI, was issued a Form FDA 483 with five repeat observations following an inspection from May 31 to June 11, 2018. The inspection revealed significant and persistent deficiencies in the firm's quality system. These issues include inadequate procedures for corrective and preventive actions, complaint handling, nonconforming product disposition, servicing activities, and employee training.

Company: Criticare Technologies, Inc.
Inspection Date: June 11, 2018
Product Type: Device
Office: Division of Northeast Imports
Person: Maryam Tabatabaie (issuing_officer)

Open in Dashboard

ID · 16ead53d-78a7-4bc3-bd21-8f34d6947c02