FDA 483 - VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products - July 19, 2018

Vit-Sea Products Int'l, Inc. dba Wachters' Organic Sea Products, a dietary supplement manufacturer in Daly City, CA, was cited for numerous significant and repeat violations of good manufacturing practices. The firm failed to maintain accurate batch records, lacked proper master manufacturing records and product specifications, and had severely deficient quality control operations with untrained personnel. Issues also included inadequate contamination prevention, improper use of sanitizing agents, poor storage conditions for raw materials, and a complete failure to investigate product complaints or collect representative samples.