MRP, LLC dba AquabilitiOctober 18, 2022

FDA 483 - MRP, LLC dba Aquabiliti - October 18, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

MRP, LLC dba Aquabiliti in Nashville, TN, was inspected and received a Form 483 with two observations. The inspection revealed inadequate procedures for controlling storage areas, leading to product mix-up risks and issues with material identification. Additionally, the firm failed to adequately document corrective and preventive actions related to Design History File updates for their sterile flush syringes.

Company: MRP, LLC dba Aquabiliti
Inspection Date: October 18, 2022
Product Type: Device
Office: New Orleans District Office
People: Jamie P. Webb
Mary A. Millner

Open in Dashboard

ID · c990fd1d-4c46-4e4f-9044-05609656a633