Ningbo Pulisi Daily Chemical Products Co., Ltd – FDA 483, Feb 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.