Certified Safety Mfg IncOctober 15, 2019

FDA 483 - Certified Safety Mfg Inc - October 15, 2019

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 Certified Safety Mfg Inc

Record Details

Certified Safety Mfg Inc, a manufacturer/repackager in Kansas City, MO, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, equipment calibration, and device history records. Several observations, including issues with nonconforming product control, quality audit frequency, and training, were repeat findings from a previous inspection.

Company: Certified Safety Mfg Inc
Inspection Date: October 15, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - West II
Person: Eric C. Fox

Open in Dashboard

ID · 2dea9ed2-5b09-48e3-87b5-74c80d8c394c