A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the…
Affected lots: (a) lot IM458501, Exp 10/2018 (b) lot IM447128, Exp 07/2018, lot IM445515
During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, and Holding Operations for Dietary…
Food and Drug Administration (FDA) conducted an inspection of your facility located at 267 E 1400 S, Suite 101, St George, Utah , where our investigators found a number of violations of the Current Good…