FDA 483 - Dextrum Laboratories Inc. - December 16, 2022

During an FDA inspection conducted from December 12-16, 2022, Dextrum Laboratories Inc., an OTC drug manufacturer in Miami, FL, received a Form 483 detailing significant observations regarding current Good Manufacturing Practices (cGMP). The main issues highlighted a lack of written procedures for reprocessing drug batches, leading to rework activities without adequate controls or quality assurance review. Equipment design and maintenance were also problematic, including an inadequate water system, uncovered mixing tanks exposed to potential contamination, and a failure to investigate microbial failures.

Further violations involved inadequate contamination prevention, such as using raw materials received in open, damaged bags, and the absence of cleaning validation for critical manufacturing equipment. The firm also lacked a comprehensive stability testing program for finished products, proper calibration records for measurement equipment, and sufficient microbial testing for objectionable organisms like Burkholderia cepacia in water and products. Additionally, quality control procedures were not consistently followed, and equipment status was not clearly identified. Addressing these deficiencies is crucial for Dextrum Laboratories Inc. to ensure compliance with regulatory standards for drug manufacturing.