The U.S. Food and Drug Administration (FDA) published two warning letters last week that were issued in late May. CJ Dairy Farm of Delevan, NY, received a warning letter after selling two calves for slaughter in June 2013 that FDA officials considered adulterated because of unacceptable levels of drug residues in their tissues. Kidney tissue samples from the animals showed the presence of desfuroylceftiofur at 2.1 and 1.67 parts per million (ppm). FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle meant for human consumption. The other letter was sent to AMK Food Export of Homogama, Sri Lanka. When FDA inspected the processing facility in December 2013, the agency issued “serious violations” of Emergency Permit Control regulations, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulations, the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations, and Current Good Manufacturing Practice regulations. The company responded in January, describing corrections to the agency’s observations, but FDA issued another letter because it stated that AMK had not made “adequate corrections.” Significant violations that FDA indicated persist include failure to:

  • Provide information on scheduled processes, including the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size;
  • Test its mercury-in-glass (MIG) thermometer against a known accurate standard as the reference instrument for indicating the process temperature of steam;
  • List the critical control points for processing and storage in the firm’s seafood HACCP plan for tuna.

In each warning letter, FDA requested that the firms send written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.