Gemini Pharmaceuticals, Inc. – FDA EIR, Jun 30, 2015

An FDA inspection of Gemini Pharmaceuticals, Inc., an OTC drug and dietary supplement manufacturer in Commack, NY, was conducted from June 23 to June 30, 2015. This inspection, carried out under the FDA's drug process inspection work plan, thoroughly reviewed the company's quality, facilities and equipment, laboratory, and production systems. Following the inspection, an FDA Form 483 was issued, outlining several critical observations.

The key violations noted included deficiencies in equipment design, specifically that manufacturing equipment was not appropriate for its intended operational use. The firm also failed to visually examine reserve samples from drug product lots at least annually for evidence of deterioration. Additionally, batch production and control records were incomplete, lacking the identification of personnel responsible for significant steps in the operation. Lastly, laboratory controls were found to be inadequate, as they did not establish scientifically sound specifications and test procedures to ensure drug products conformed to appropriate standards of identity, strength, quality, and purity. In response to these findings, Gemini Pharmaceuticals' management committed to providing a written reply addressing all observations listed in the FDA Form 483.