FDA 483 - Inopak Ltd - July 20, 2018

An FDA inspection of Inopak Ltd, an OTC drug manufacturer, revealed significant deficiencies across its quality, laboratory, production, and equipment systems. The firm failed to thoroughly investigate microbial contamination in distributed products, lacked proper quality control oversight, and did not have essential written programs for annual product reviews, stability testing, process validation, equipment maintenance, and cleaning validation. Several observations, particularly regarding process validation, were repeat findings from previous inspections, indicating persistent non-compliance.