FDA 483 - Dr. Brite LLC - April 05, 2024

Dr. Brite LLC, a drug manufacturer in Fullerton, CA, was cited for significant deficiencies in its quality control, production, and laboratory systems during an FDA inspection. Observations included a lack of written procedures, inadequate batch records, insufficient component and finished product testing, and no stability program to support expiration dates. These issues indicate a severe lack of adherence to current good manufacturing practices.