FDA 483 - Romark Global Pharma, LLC - April 27, 2020

An FDA inspection of Romark Global Pharma, LLC in Manati, PR, revealed significant deficiencies in preventing microbiological contamination in drug products, particularly NT-300 tablets. The firm's procedures for manufacturing, equipment cleaning, and quality control were found to be inadequate, leading to product rejections and a high risk of contamination. These issues indicate a systemic failure in maintaining a state of control over microbial quality.