FDA 483 - VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products - April 17, 2015

An FDA inspection of VitaSea Products Int'l, dba Wachters Organic Sea Products in Daly City, CA, revealed numerous deficiencies in their dietary supplement manufacturing processes. The firm lacked essential written procedures for quality control, cleaning, and sampling, and failed to establish specifications for manufacturing stages. Additionally, observations noted inadequate contamination controls and deviations from master manufacturing records, indicating a severe lack of adherence to good manufacturing practices.