FDA 483 - Ningbo Pulisi Daily Chemical Products Co., Ltd - February 28, 2019

An FDA inspection of Ningbo Pulisi Daily Chemical Products Co., Ltd, an OTC drug manufacturer, revealed 18 significant deficiencies in their manufacturing operations. The observations highlight a widespread lack of adherence to Good Manufacturing Practices, including inadequate product testing, poor facility and equipment maintenance, insufficient process validation, and deficient record-keeping and quality control procedures. These issues raise concerns about the identity, strength, quality, and purity of their OTC drug products.