Under FSMA the FDA has issued a final rule to allow the FDA to copy records for both food and dietary supplements in an emergency situation. To avoid additional problems it is necessary to ensure your company is in compliance with dietary supplement GMPs.
The FDA has issued a final rule based on the Food Safety Modernization Act (FSMA), which allows the FDA access to records and copy those records in an emergency situation. The scope of the rule spans to all food including dietary supplements. An emergency situation could be defined as a situation where the FDA has reasonable belief that a food or dietary supplement presents a threat of a serious adverse event.
Within the scope of the rule FDA is permitted to inspect and copy records from manufacturers, processors, packers, distributors, warehouses, importers or any other entity involved in handling of the suspected food. Some examples of records that could be targeted would include manufacturing records, information on receipt of raw materials, distribution records, customer lists, testing records, and complaint and adverse event records, so it is of utmost importance to ensure you have good record keeping practices and are in compliance with dietary supplement GMPs.
For FDA to gain access to records of foods and dietary supplement that they suspect could pose a threat of a serious adverse event, the FDA must first file a FDA form 482c (Notice of Inspection – Request for Records) to the company of the suspected food or dietary supplement. The FDA must also obtain consent/agreement from the Office of Enforcement Operations who coordinates with FDA’s Office of Emergency Operations before any action is taken. Once there is agreement, The Office of Emergency Operations must then notify the relevant FDA office such as the Center for Food Safety and Nutrition (CFSAN) of the situation. The Office of Chief Counsel is also consulted on the scope of the records and when all organizations within FDA are in concurrence regarding whether the situation warrants an emergency request and the scope of the request, the relevant District moves forward with issuance of the FDA form 482c.
Once the form 482c is issued, refusal to permit access to copying records quested is prohibited under the Federal Food, Drug & Cosmetics act. Refusal to permit may result in suspension of the food facility registration, detention or seizure of products, issuance of a mandatory recall, or a court injunction.
The only records that a company may refuse access to are financial data, pricing data, personnel data, research data, sales data, formulations with quantities and instructions, and records from farms, restaurants or those related to food under exclusive jurisdiction of USDA.
FDA has advised that all records copied will remain confidential, however, even with confidential records the suspected food company is now at a higher risk of being exposed to additional violations. Since all contractors of the suspected food or dietary supplement may be targeted for records, it may lead to greater scrutiny when a food or dietary supplement company chooses a contractor. This will also reinforce companies to be diligent with their record keeping and ensure that records are compliant with the relevant food or dietary supplement GMPs. It is also important that SOPs for record keeping be designed in way that will facilitate FDA review during a routine inspection or emergency response.
The food and dietary supplement industry are now under more scrutiny than ever and FSMA is continuing to have a major impact on industry and compliance with the GMPs. It is now up to all companies to ensure they are in full compliance and keep an eye on the upcoming implementation dates for additional FSMA rules.
dicentra offers dietary supplement GMP auditing to help you ensure your facility is compliant and your record keeping practices are correct and current. We can assist by conducting scheduled audits for compliance or after a 482c is received.
dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.