Stallion Laboratories Private LimitedMarch 24, 2023

FDA 483 - Stallion Laboratories Private Limited - March 24, 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 Stallion Laboratories Private Limited

Record Details

Stallion Laboratories Private Limited in Ahmedabad, India, was cited with two observations during an FDA inspection. The firm failed to establish adequate control procedures for validating manufacturing processes, specifically regarding discrepancies in performance qualification parameters. Additionally, the inspection revealed inadequate written procedures for production and process controls, leading to potential product contamination due to poor sanitation practices by an operator.

Company: Stallion Laboratories Private Limited
Inspection Date: March 24, 2023
Product Type: Drugs
Office: Office of Inspections and Investigations
People: Marian E. Ramirez (investigator)
Alan A. Rivera

Open in Dashboard

ID · c60eaa32-a462-4906-a1d2-d54d902bff30