Gemini Pharmaceuticals, Inc.June 1, 2011

FDA 483 - Gemini Pharmaceuticals, Inc. - June 01, 2011

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 Gemini Pharmaceuticals, Inc.

Record Details

An FDA inspection of Gemini Pharmaceuticals, Inc. in Commack, NY, a drug manufacturer, revealed two significant observations. The firm's compression process validation for Acetaminophen 500mg tablets was found deficient, failing to demonstrate consistent product specifications over time. Additionally, the written stability program for drug products lacked proper descriptions of storage conditions and failed to address temperature mapping and sample handling procedures.

Company: Gemini Pharmaceuticals, Inc.
Inspection Date: June 1, 2011
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Alice S. Tsao (Consumer Safety Officer at FDA)

Open in Dashboard

ID · d3335f63-f681-4529-a490-7f5be013903e