Kite Pharma, Inc.October 22, 2021

FDA 483 - Kite Pharma, Inc. - October 22, 2021

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 Kite Pharma, Inc.

Record Details

Kite Pharma Inc. in El Segundo, CA, received a Form 483 with two observations. The inspection revealed deficiencies in environmental monitoring within aseptic processing areas, specifically regarding the placement and requirement for active viable air sampling in Biological Safety Cabinets. Additionally, the firm failed to promptly perform investigations into serious and unexpected adverse events related to product infections reported via MedWatch.

Company: Kite Pharma, Inc.
Inspection Date: October 22, 2021
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
People: Laurel A. Beer
Gene D. Arcy

Open in Dashboard

ID · fa4d9c4c-8314-49c9-a71d-7624cebe810a