Nestle Mexico, S.A. de C.V. Coatepec – FDA EIR, Jan 19, 2023

An FDA inspection of Nestle Mexico, S.A. de C.V. Coatepec was conducted from January 16-19, 2023. This comprehensive, routine foreign inspection assessed the facility, which manufactures spray-dried milk powder for toddlers and sweetened condensed milk exported to the U.S. The inspection was performed under various FDA compliance programs, including 7303.803, 7303.040, and 7321.005, and specifically evaluated the firm's adherence to 21 CFR Part 117, which covers Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods. Significantly, no FDA Form 483, Inspectional Observations, was issued, indicating that no formal violations requiring written response were identified. However, a key discussion was held with the firm's management regarding product labeling for powdered milk beverages. The inspector noted that the "statement of identity" (e.g., "Milk Powder") was not sufficiently pronounced on the primary display panel, failing to meet criteria for prominence, such as being parallel to the base or adequately sized relative to other prominent text. The inspection also covered a consumer complaint (165742) concerning alleged lead levels, which the firm investigated without finding discrepancies, as they had not received it prior. Other food safety-related complaints were also reviewed, with the firm demonstrating adequate investigation. The FDA representative suggested the firm add the FDA to their recall program contact list for Reportable Food Registry purposes. While no formal actions were required, the labeling discussion highlights an area for the company to address for full regulatory alignment.