Alchem Laboratories Corporation – FDA 483, Feb 14, 2005

Alchem Laboratories, Corporation, an Active Pharmaceutical Ingredient (API) manufacturer in Alachua, FL, was inspected by the FDA from February 14-16, 2005. The inspection revealed significant deficiencies in material handling, laboratory record-keeping, environmental monitoring, and self-audit procedures. These issues indicate a lack of adherence to established GMP processes and quality assurance protocols.