FDA EIR - Gadot Biochemical Industries Ltd - December 08, 2019

An FDA inspection of Gadot Biochemical Industries Ltd, an Israeli manufacturer of citric acid salts and phosphate salts used in food additives and dietary supplements, was conducted on December 8, 2019. The purpose of the inspection was to evaluate the firm's compliance with the regulatory requirements outlined in 21 CFR Part 117, which covers Current Good Manufacturing Practice and Preventive Controls for Human Food.

The inspection, conducted by a Dedicated Foreign Food Cadre investigator, involved a factory walkthrough of the Tri Sodium Citrate process flow and a comprehensive review of various documents. These included raw material receiving records, batch records, finished product analyses, cleaning monitoring records, water test results, sanitation standard operating procedures (SSOPs), complaint procedures, recall procedures, pest control monitoring, and training records.

Crucially, the inspection found no deficiencies that would warrant the issuance of an FDA Form 483, Inspectional Observations. Therefore, no adverse conditions or significant violations were identified. The firm was noted to have a qualified individual for preventive controls and robust procedures for training, complaints, and recalls, including mock recalls. No samples were collected, and no import alerts were found for the firm's products. This indicates the facility was operating in compliance with the evaluated U.S. food safety regulations at the time of inspection.