FDA EIR - Nestle Mexico, S.A. de C.V. - August 10, 2017

An FDA inspection of Nestle Mexico, S.A. de C.V. in Lagos de Moreno, Jalisco, Mexico, was conducted from August 28-30. This comprehensive inspection focused on the company's Low Acid Canned Food (LACF) table cream manufacturing operations, adhering to FDA's Preventive Controls and LACF regulations, as well as general food labeling requirements for products exported to the United States.

Key observations included several deficiencies in the food safety plan. The plan failed to identify and include specific controls for *Bacillus cereus* toxin hazards during raw milk receiving and processing, and for preventing undeclared allergens due to incorrect labeling. Inspectors also noted that a process authority did not evaluate LACF table cream lots prior to reconditioning. Additionally, finished products and those intended for reconditioning were found stored together and not clearly marked in the warehouse, and live flies were observed in the milk reception area.

Although no official FDA Form 483 was issued, these concerns were discussed verbally with company management at the closeout meeting. Nestle Mexico's management acknowledged the deficiencies, pledged to implement corrective actions, and submitted an action plan within 15 days, demonstrating a commitment to addressing the identified issues.