FDA 483 - NATURA BISSE INTERNATIONAL SA - September 16, 2022

Natura Bisse International, Inc., an OTC drug manufacturer in Cerdanyola Del Valles, Spain, received a Form 483 for deficiencies in laboratory controls and equipment design. Observations included inadequate media testing for microbial recovery and lack of growth promotion, alongside issues with equipment design, alarm management, performance qualification, and timely investigation of temperature excursions. These findings indicate a need for improved quality oversight in critical manufacturing and testing processes.