FDA 483 - Nulatex Sdn. Bhd. - October 19, 2023

Nulatex Sdn. Bhd. in Kluang, Malaysia, a manufacturer of latex products, was cited by the FDA for significant deficiencies in its quality system. The inspection revealed inadequate procedures for complaint handling, corrective and preventive actions (CAPA), and the control of in-process products. These issues indicate a lack of robust processes and proper documentation, potentially impacting product quality and safety.