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Recordkeeping Requirements for High-risk Foods


  • They must relate only to information that is reasonably available and appropriate
  • they must be science-based;
  • they may not prescribe specific technologies to maintain records;
  • the public health benefits must outweigh the cost of complying with the requirements;
  • they must be practical for facilities of varying sizes and capabilities;
  • to the extent practical, they may not require a facility to change business systems to comply;
  • they must allow for the maintenance of records at a reasonably accessible location, provided that the records can be made available to FDA within 24 hours of a request;
  • they may not require a full pedigree, or a record of the complete previous distribution history of the food from the point of origin