FDA 483 - Bactolac Pharmaceutical, Inc. - November 19, 2021

Bactolac Pharmaceutical, Inc. in Hauppauge, NY, was cited for significant deficiencies in its quality control and specification establishment for dietary supplements. Observations included failure to verify finished product specifications, not rejecting components exceeding heavy metal limits, and lacking established specifications for contamination and upper limits for ingredients. These issues indicate a lack of robust quality control processes for ensuring product safety and quality.