Imagine Milling Technologies, LLCFebruary 1, 2023

FDA 483 - Imagine Milling Technologies, LLC - February 01, 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 Imagine Milling Technologies, LLC

Record Details

Imagine Milling Technologies, LLC, a medical device manufacturer in Chantilly, VA, received a Form FDA-483 with a repeat observation during an inspection from January 30 to February 1, 2023. The firm failed to perform required quality audits, providing evidence only for a 2019 third-party audit and admitting no internal audits were conducted from 2020-2022. This indicates a significant and recurring lapse in their quality system oversight.

Company: Imagine Milling Technologies, LLC
Inspection Date: February 1, 2023
Product Type: Device
Office: Office of Regulatory Affairs
Person: Jude C. Dike

Open in Dashboard

ID · 5c49b838-2ec5-4609-bdce-ee58a2579492