FDA 483 - Ningbo BST Clean and Care Products Co., Ltd - June 14, 2019

An FDA inspection of Ningbo BST Clean And Care Products Co., Ltd. in Fenghua, Ningbo, an OTC drug manufacturer, revealed 21 significant deficiencies across its operations. The firm lacked fundamental written procedures for quality control, employee training, annual product reviews, equipment maintenance, and process controls. Additionally, the facility was poorly maintained, equipment was not qualified or calibrated, and laboratory controls, stability programs, and record-keeping were severely inadequate, indicating a widespread failure to adhere to current good manufacturing practices.