FDA 483 - Inopak Ltd - June 18, 2021

Inopak Ltd, an OTC drug manufacturer in Ringwood, NJ, was inspected by the FDA from June 14-18, 2021. The inspection revealed significant deficiencies across multiple areas, including a lack of written procedures for production and process controls, inadequate quality control unit responsibilities, and insufficient laboratory controls. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of their drug products.