Bocchi's Sanitation Flies In Face Of Regs, FDA Finds Following Medline Recall
Executive Summary
Warning letter to Bocchi Laboratories details violations of FDA regulations agency inspectors found in an inspection of firm's facility from late March through early June 2018 "in response to an outbreak of Burkholderia cepacia associated with" a cleanser it manufactures. In addition to product adulteration due to microbial contamination, FDA found Bocchi in violation of drug GMPs because products were labeled with indications rendering them drugs under FDA regulations.