FDA 483 - Seatex LLC - October 20, 2023

Seatex LLC, an OTC drug manufacturer in Rosenberg, TX, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed inadequate laboratory controls, a lack of process validation, insufficient stability data for expiration dates, and incomplete laboratory records. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its drug products.