FDA 483 - Bactolac Pharmaceutical, Inc. - September 24, 2025

Bactolac Pharmaceutical, Inc. in Hauppauge, NY, a dietary supplement manufacturer, received a Form 483 with five observations. The inspection revealed significant issues with product and component specifications, including a lack of established limits for heavy metals and purity, and a failure to follow laboratory procedures for arsenic speciation. Repeated observations highlighted deficiencies in identity testing for dietary ingredients and inadequate scientific rationale for ensuring finished product specifications are met.