FDA EIR - Gemini Pharmaceuticals, Inc. - February 16, 2018

Gemini Pharmaceuticals, Inc. underwent an FDA inspection from February 13-16, 2018, as an Over-The-Counter (OTC) drug and dietary supplements manufacturer in Commack, NY. The inspection, conducted pursuant to Drug Good Manufacturing Practices (GMP) and CPGM 7356.002, evaluated the firm's Quality, Facilities and Equipment, and Production & Materials systems. An FDA Form 483 was issued, detailing several significant observations.

Main violations included inadequate facility maintenance, specifically in blending rooms which were found in a poor state of repair with material buildup and deteriorating wall surfaces, posing potential contamination risks. Similarly, a pharmacy dispensing room lacked adequate environmental controls due to structural deficiencies and disrepair. The company also failed to adhere to its written procedures for sampling and examining packaging materials, as evidenced by open sampling room doors and incomplete inspection of collected samples. Furthermore, procedures for the storage and annual visual examination of reserve samples were not consistently followed, with records indicating samples were not properly inspected or pulled according to established guidelines, referencing regulatory requirements such as 21 CFR 211. Management acknowledged all observations, agreeing to take corrective actions and provide a written response within 15 business days. The firm initiated some voluntary corrections during the inspection, including drafting updated Standard Operating Procedures for facility cleaning, revising sampling protocols, and improving documentation for equipment usage, demonstrating a commitment to addressing the identified deficiencies.