Ionetix CorporationJuly 12, 2019

FDA 483 - Ionetix Corporation - July 12, 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 Ionetix Corporation

Record Details

Ionetix Corporation, a PET drug manufacturer in Kansas City, KS, was cited for three observations during an FDA inspection. The firm lacked adequate production and process controls, specifically regarding media fill simulations for aseptic processing. Additionally, the inspection found failures to follow written quality assurance procedures and deficiencies in laboratory analytical methods, including employee training for visual inspections.

Company: Ionetix Corporation
Inspection Date: July 12, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Zachary L. Stamm (Pharmaceutical Program Expert)

Open in Dashboard

ID · 2d06477e-fa6f-46a4-81b9-10fe4479c948