FDA 483 - UBI Pharma, Inc. - June 06, 2023

UBI Pharma, Inc., a sterile drug manufacturer in Hukou, Taiwan, received a Form 483 with six observations following an inspection from May 25 to June 6, 2023. The observations primarily concern significant deficiencies in aseptic processing validation, microbiological contamination prevention procedures, equipment cleaning and maintenance, employee training, production and process controls, and laboratory record documentation. These issues indicate a lack of adequate controls to ensure the sterility, quality, and purity of drug products.