FDA 483 - Dipasa USA, Inc - September 06, 2023

Dipasa USA, Inc. in Brownsville, TX, received a repeat observation for failing to implement process preventive control and monitoring procedures. The firm did not adequately control and document parameters for toaster heat processing of sesame products, deviating from its validation study. Additionally, monitoring and verification records were not reviewed by a PCQI or under PCQI oversight.