FDA EIR - HAYASHIBARA CO., LTD. OKAYAMA FUNCTIONAL SACCHARIDE PLANT - June 11, 2018

The FDA conducted its initial inspection of Hayashibara Co. Ltd., Okayama Functional Saccharide Plant, a food additive manufacturer located in Okayama, Japan, on June 11, 2018. This comprehensive one-day inspection was carried out under Compliance Program 7303.803, focusing on various aspects of their operations, including ingredient handling, processing, distribution, complaint management, and sanitation practices.

The inspection concluded with highly positive findings. Notably, no FDA Form 483, 'Inspectional Observations,' was issued, indicating no significant violations or objectionable conditions were identified. Furthermore, no discussion items requiring management attention were noted. The facility was found to be adequate and sanitary, with strict adherence to Good Manufacturing Practices (GMPs) and effective pest control measures.

Hayashibara Co. Ltd. demonstrated robust internal systems, including a formal employee training program covering sanitation and hygiene, comprehensive complaint procedures based on ISO 9000 standards, and established recall protocols with mock recall exercises. The firm also had a food safety plan in place, identifying Operational Prerequisite Programs (OPRPs) and Critical Control Points (CCPs) within their manufacturing process. Although no issues were found, the FDA provided the facility manager with information on the Reportable Food Registry, FSMA Final Rule on Preventive Controls for Human Food, Sanitary Transport, and Intentional Adulteration. No required actions were mandated as the inspection did not reveal any deficiencies.