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

Source: https://www.keypedia.com/records/483/gemini-pharmaceuticals-inc/d3335f63-f681-4529-a490-7f5be013903e

> FDA 483 for Gemini Pharmaceuticals, Inc. on June 01, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gemini Pharmaceuticals, Inc.
- Inspection Date: 2011-06-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

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## Related Officers

- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)

Company: https://www.keypedia.com/companies/gemini-pharmaceuticals-inc/9e83f65c-3863-4ad6-a434-b37d9673ac0f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961