US FDA Demands New Requirements of Records Access

To bring legislation in line with provisions of the Food Safety Modernization Act 2010 (FSMA) the US Food and Drug Administration (FDA) issued an interim final rule and draft guidance for record access requirements on February 23, 2012. The FDA has also updated a question and answer section to the guidance and the interim final rule became effective on March 1, 2012.

The regulations apply to importers, manufacturers, processors, packers, transporters, distributors, receivers and holders of bulk food in the USA. The FDA can request access to the records kept by a company should there exist a reasonable cause to believe a product may be adulterated or that contamination by another product or packaging presents a threat to humans and animals. Exempted from record access requirements are farms, restaurants or retailers of food supplied directly to the consumer and food packaging material except when filled with food and products under United States Department of Agriculture (USDA) jurisdiction.

To enable its surveillance function, the US FDA is granted legal access to all manufacturing records, records of raw materials (ingredients and packaging), receipt records, product distribution records, test records, recall records and reportable food records, customer distribution records, complaint and adverse event records. However, the US FDA does not have the right to access recipes, financial records, pricing data, personnel records, research records and sales records with the exception of shipment data to customers.

It is an obligation for importers, manufacturers, processors and packers to keep records about each specific lot. In addition, importers must also continue to keep records required by the Bioterrorism Act. Precise requirements for the records that have to be kept are found in Title 21 of the Code of Federal Regulations (CFR) section 1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=1), subparts I and J.

Files must be kept for 2 years from the last date recorded and records must be provided within 24 hours of a formal request by the FDA. In the event that the records requested are not provided within 24 hours, the FDA can suspend the facility’s registration, detain or seize products, demand mandatory recall and impose an injunction.

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This release was published on openPR.