FDA 483 - Bakelite Chemicals LLC - November 20, 2019

Georgia Pacific Chemical LLC in Albany, OR, was cited for significant deficiencies during an FDA inspection. Observations included a lack of appropriate controls over computerized laboratory systems, inadequate investigation of an out-of-specification result for formaldehyde, and incomplete batch production records lacking labeling copies. These issues indicate a moderate level of non-compliance with good manufacturing practices, particularly concerning data integrity and quality control.