FDA 483 - Bactolac Pharmaceutical, Inc. - September 24, 2025
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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.
ID · d58b3e6a-6b5d-4d3f-881d-499771520cb9