FDA 483 - Bactolac Pharmaceutical, Inc. - February 07, 2025

An FDA inspection of Bactolac Pharmaceutical, Inc. in Hauppauge, NY, revealed significant deficiencies in quality control and facility maintenance for dietary supplements. Observations included inadequate testing for finished product specifications and raw material identity, a lack of established contamination limits for components, and improper storage of rejected products. Additionally, the facility exhibited a severe pest infestation and unsanitary conditions, indicating a high risk of product adulteration and contamination.