Only 12 companies out of more than 14,000 inspected in the last five months by FDA for compliance with its BSE feed rule required serious action, according to the latest FDA compliance statistics. Another 80 firms were cited for minor infractions requiring voluntary remedial action, while two firms were referred to state regulators.
The FDA database www.fda.gov was updated April 23, with data current as of April 17.
The serious infractions, which included labeling, record-keeping and other potential cross contamination problems, generated warning letters and allow six months to fix. If no action is taken the agency can get an injunction against the firm.