FDA 483 - Gingi-Pak A Division of the Belport Co., Inc - November 12, 2021

An FDA inspection of Belport Co Inc. dba Gingi-Pak in Camarillo, CA, a drug manufacturer, revealed significant deficiencies in their quality systems. Observations included a lack of microbiological testing for water and drug products, inadequate investigations into out-of-specification results, and a missing stability testing program. The firm also failed to qualify equipment, properly document packaging and cleaning activities, and maintain complete batch production records.