Herdez S.A. de C.V Planta Mexico -McCormick de Mexico – FDA EIR, Apr 24, 2019

An FDA surveillance inspection of Herdez S.A. de C.V. Planta Mexico - McCormick de Mexico, a manufacturer of mayonnaise and other condiments, was conducted from April 22-24, 2019. This inspection was the firm's first under the new Preventive Control Regulations, 21 CFR 117, focusing on Current Good Manufacturing Practices and Risk-Based Preventive Controls in Human Foods. While no FDA Form 483 was issued, the investigator identified four verbal observations related to the firm's Food Safety Plan, specifically concerning the product "Mayonnaise with Lemon Concentrate." Main issues included the hazard analysis for certain ingredients, which understated risks despite existing controls; the omission of water as an ingredient requiring biological hazard controls in the Hazard Analysis and HACCP plan; the lack of identified physical hazards like foreign matter and metal inclusions in the hazard analysis for receiving and processing steps, despite existing filters and supplier controls; and employee training materials not explicitly advising staff to report illnesses. The company promptly performed voluntary corrections for all observations during the inspection, revising their Hazard Analysis, HACCP plan, and employee training procedures. No further regulatory actions were required due to these immediate corrections.