FDA 483 - VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products - June 19, 2017

An FDA inspection of Vit-sea Products Int'l, dba Wachters Organic Sea Products in Daly City, CA, a dietary supplement manufacturer, revealed four significant deficiencies. The firm failed to establish specifications, written quality control procedures, and adequate master manufacturing records. All observations were repeat citations from a previous Warning Letter, indicating a serious and unaddressed lack of compliance with manufacturing regulations.