FDA inspected Bioseutica®'s plant in Zeewolde(NTI)

In October 2019, the Food and Drug Administration (FDA) conducted a thorough inspection of our food production plant located in Zeewolde, Netherlands.

This inspection was carried out under the stringent guidelines set forth by the "Preventive Controls and Sanitary Human Food Operations-7303.040 Domestic and Imported Nutrition Labelling and Education Act of 1990," along with the associated MARCS # 126299. Preventive Controls and Sanitary Human Food Operations is a comprehensive regulatory framework to ensure that food manufacturing facilities adhere to the highest food safety and hygiene standards.

The inspection process encompasses a wide array of checks and balances intended to identify and mitigate potential hazards in food production. These include but are not limited to preventive controls for known or reasonably foreseeable biological, chemical, and physical hazards and sanitary controls to maintain cleanliness and prevent contamination throughout the production process. During this inspection, the FDA meticulously reviewed our plant’s adherence to these regulations.

This involved thoroughly examining our preventive control measures and protocols to address potential food safety issues before they occur preemptively. These controls are critical in ensuring that all food products manufactured at our facility are safe for consumption and meet regulatory standards. In addition to the preventive controls, the inspection evaluated our compliance with sanitary operations.

This aspect of the inspection focuses on the cleanliness and maintenance of the production environment, ensuring that all areas where food is processed, stored, or handled are kept in a sanitary condition. The inspectors assessed our cleaning procedures, pest control measures, and employee hygiene practices, among other factors. The Nutrition Labelling and Education Act (NLEA) of 1990, under which this inspection was conducted, mandates accurate and informative labeling on all food products. The Act ensures that consumers receive essential information about the nutritional content of the food they purchase, which is crucial for making informed dietary choices. Compliance with this Act involves detailed checks on the accuracy of the labels, the adequacy of nutritional information provided, and the proper display of allergen warnings and ingredient lists. Our Zeewolde plant demonstrated exemplary compliance with all applicable regulations throughout the inspection.

The FDA inspectors observed our manufacturing processes, reviewed our documentation, and interviewed our staff to ensure that every aspect of our operation met their rigorous standards. Our team’s commitment to maintaining high food safety and quality standards was evident in every inspection phase. One of the significant outcomes of this inspection was the absence of any FDA483 Inspectional Observations. The FDA Form 483 is issued when investigators observe any conditions that may violate the Food and Drug Administration (FDA) Act and related Acts. Receiving no such observations indicates that the FDA found no deficiencies during their inspection that warranted further action or correction.

The compliance of our Zeewolde plant with the Preventive Controls and Sanitary Human Food Operations regulations, as well as the Nutrition Labelling and Education Act of 1990, underscores our dedication to producing safe, high-quality food products. It reflects our ongoing commitment to upholding the highest standards in food safety and regulatory compliance. This successful inspection not only assures our consumers of the safety and integrity of our products but also reinforces our standing in the food manufacturing industry as a company that prioritizes excellence in every aspect of our operations. Our adherence to these stringent regulations ensures that we continue to provide nutritious and safe food products to our customers, meeting their expectations and contributing to their well-being. In conclusion, the FDA's thorough inspection of our Zeewolde (NL) food production plant in October 2019 confirmed our compliance with the Preventive Controls and Sanitary Human Food Operations-7303.040, the Domestic and Imported Nutrition Labelling and Education Act of 1990, and MARCS # 126299. The absence of any FDA483 Inspectional Observations is a testament to our commitment to maintaining the highest standards of food safety and quality, ensuring that our products meet regulatory requirements and are safe for consumer consumption.