FDA 483 - Sterling Technology, Inc. - July 01, 2022

An FDA inspection of Sterling Technology, Inc., a bovine colostrum manufacturer, revealed deficiencies in their written process preventive control procedures. Specifically, the firm's HACCP Plan for Colostrum Powder did not adequately control antibiotic hazards, lacking sufficient testing for various drug classes and validation data for screening products. Additionally, the firm was cited for improper handling of antibiotic-adulterated raw food material and unauthorized diversion of drug residue positive products to animal feed.