ABC PharmaceuticalsFebruary 27, 2025

FDA 483 - ABC Pharmaceuticals - February 27, 2025

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 ABC Pharmaceuticals

Record Details

Revance Therapeutics Inc. in Newark, CA, was inspected by the FDA from February 19-27, 2025. The inspection revealed a significant deficiency in laboratory controls, specifically regarding bacterial endotoxin testing procedures. The firm's SOP lacked instructions for sample mixing, and samples were improperly collected and stored, indicating a failure to ensure product quality and purity.

Company: ABC Pharmaceuticals
Inspection Date: February 27, 2025
Product Type: Biologics
Office: San Francisco District Office
People: Philip F. Istafanos
Linda Thai (Team Biologics Staff)

Open in Dashboard

ID · de22bb22-e4de-4192-adbc-cc975ed8c2f1