Rinovum Subsidiary 2 LLCSeptember 15, 2023

FDA 483 - Rinovum Subsidiary 2 LLC - September 15, 2023

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 Rinovum Subsidiary 2 LLC

Record Details

An FDA inspection of Rinovum Subsidiary 2 LLC in Monroeville, PA, identified a significant deficiency in the firm's complaint handling system. The company failed to adequately review, evaluate, and investigate customer complaints related to potential device, labeling, and packaging failures. This issue was noted as a repeat observation from a previous inspection, highlighting a persistent non-compliance.

Company: Rinovum Subsidiary 2 LLC
Inspection Date: September 15, 2023
Product Type: Device
Office: Philadelphia District Office
Person: Dennis R. Hock (issuing_officer)

Open in Dashboard

ID · 912c31b7-b4c1-40f3-a839-26a47cd4d3f3