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FDA Warning Letters: Puerto Rico Egg Producer, U.S. Cattle and Dairy Farms

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An egg production facility in Puerto Rico was the target of a March 11, 2015, warning letter from the U.S. Food and Drug Administration (FDA), which was only recently made public.

FDA Warning

The letter followed a FDA inspection this past Dec. 2-10, 2014, that found the facility was in serious violation of production, storage and transportation regulations aimed at the control of Salmonella enteritidis (SE).  Noncompliance with these regulations means that eggs from the facility are considered to be adulterated, FDA stated.  The warning letter was directed to Glidden Martinez, owner of Granja La Cabaña Inc., the egg production facility located in Utuado, PR. Before sending Martinez the warning letter, FDA had shared its Form 483 inspections observations with management.  According to the warning letter, significant violations included:

In addition, four recently released FDA warning letters concerned the sale of recently slaughtered animals that returned test samples found to have unacceptable levels of animal drug residues in tissues.  Two of the letters were dated May 21, 2015. The first went to Dennis Bolling, president and chief executive officer of United Producers Inc. in Columbus, OH. The letter concerned a Holstein bull calf that did not sell at auction and was then sent to slaughter for human food.  Tissue testing by USDA’s Food Safety and Inspection Service found higher-than-permitted levels of florfenicol in liver and muscle tissues. Also found was higher-than-permitted levels of the non-steroidal anti-inflammatory drug flunixin, FDA stated.  Great Lakes Cattle Marketing Co. LLC  in St. Louis, MO, was the target of the second May 21 warning letter, which also concerned higher-than-permitted levels of florfenicol and flunixin in tissue residues from a recently slaughtered Holstein bull calf.  Two additional warning letters recently went out from FDA concerning illegal drug residues found in recently slaughtered animals.  On June 8, FDA sent a warning letter to Paulding Dairy in Paulding, OH. The letter concerned a dairy cow sold for slaughter this past September in which tissue testing later found the animal drug desfuroylceftiofur at levels higher than permitted by the agency.  And, on June 9, FDA send a warning letter to Clayholm Farms LLC in Worthington, PA, regarding a dairy cow sold in May 2014 for slaughter that turned out to have higher-than-permitted levels of desfuroylceftiofur in is kidney tissues.  In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.  Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

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