FDA 483 - Pharmalab Enterprises, Inc. - June 17, 2019

Pharmalab Enterprises, Inc. in Hialeah, FL, a manufacturer of liquid OTC drugs, dietary supplements, and medical foods, was cited for significant deficiencies across its operations. The inspection revealed inadequate laboratory controls, including deficient specifications and failure to investigate discrepancies, as well as poor production practices such as insufficient process validation and equipment maintenance. Additionally, the firm failed to conduct proper testing for dietary ingredients and finished products, lacked adequate contamination controls, and had uncalibrated instruments for medical food production.