FDA WARNING_LETTER - Gondi S.A. - April 24, 2023

The FDA issued a Warning Letter to Industria De Enlatados Alimenticios Cia Ltda Ideal, located in Portoviejo, Manabi, Ecuador, following an inspection of their low-acid canned food (LACF) facility from April 10 to April 24, 2023. The inspection was prompted by FDA laboratory analysis indicating potential under-processing of LACF seafood products, which could lead to spoilage or pathogen contamination.

Key violations identified include non-compliance with the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113). Specific issues involved deviations from the scheduled process for canned shrimp in brine, such as not meeting the minimum initial temperature and exceeding the maximum net fill weight. Additionally, inappropriate can sizes were used on multiple occasions.

As a result, the FDA placed the firm's LACF products on Import Alert #99-38, leading to potential Detention Without Physical Examination (DWPE) when products are imported into the United States. This administrative procedure is based on historical data or inspection findings suggesting non-compliance with FDA regulations.

To address these concerns, the company must ensure adherence to the Federal Food, Drug, and Cosmetic Act and applicable regulations, specifically rectifying processing deviations and ensuring proper documentation and compliance with scheduled processes. The FDA has provided detailed guidance on corrective actions necessary for the firm to be considered for removal from the Import Alert.