Wisconsin and Utah dairy operations and a cheese factory in Pennsylvania received warning letters recently made public by the Food and Drug Administration.
LeRaysville Cheese Factory Inc. in LeRaysville, PA
The Philadelphia district office of the FDA sent a warning letter Sept. 2 to owner Milton Repsher describing “significant” food safety violations at the repacking and distribution operation, some of which have persisted since 2013.
Problems served by inspectors at the operation from March 15 through April 5 included improperly labeled foods; employees’ failure to wash their hands; lack of a hand washing facilities; broken and dirty equipment; rusty and improperly repaired equipment, floors, pipes and windows; and untrained employees.
The labeling problems included failure to identify foods with “common” names, such as cheddar cheese labels that did not include the word “cheese.” Labels also did not include all of the ingredients and incorrectly identified some foods in specific violation of federal law.
Some of the food labels also failed to include the address of the business, as required by law. Inspectors also fund that some of the food was not being manufactured at the facility, but that fact was not reflected on the labeling.
“… where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as ‘Manufactured for ___’, ‘Distributed by ___’, or any other wording that expresses the facts.”
Sanitation problems cited in the Sept. 2 warning letter to the owner of the LeRaysville Cheese Factory centered on hand washing violations and improper/inadequate building and equipment repairs.
“On March 25, 2016, you informed our investigators that the hand sanitizer was full; however, upon checking it was still inoperable. This is a repeat observation from the previous inspection of April 2013 and corrective action was promised during a Regulatory Meeting with your firm in July 2013,” according to the warning letter.
“Further, a letter faxed to FDA from your facility on July 31, 2013, stated that you purchased a hand washing station. This hand washing station was found in its original box, in your firm’s storage room, during our inspection ending April 5, 2016.
“We acknowledge that your written response states that you placed hand sanitizer in the port a potty, as of April 12, 2016. We do not consider this response an acceptable method of washing and sanitizing hands.”
Inspectors observed employees handling food with dirty gloves and bare hands, in addition to other handling violations.
“These employees removed the plastic wrap from the block of cheese, and used their body to maneuver the cheese on the counter. The block of cheese came into direct contact with the employees’ street clothes,” the letter states.
“Further, in the cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office, a window was broken and another window was covered with more than a dozen dead insects.”
Other problems observed by inspectors were repeat problems found during visits in 2014.
The cheese company responded to FDA’s previous inspections, but the agency found those response letters inadequate. The company had 15 days to respond to the Sept. 2 warning letter. The FDA has not yet closed the case.
Dietsche’s Dairy in Spencer, WI
The Minneapolis, MN, district offie of the FDA sent a warning letter Dec. 7 to Marvin Dietsche and Richard L. Dietsche, co-owners of the dairy regarding illegal levels of antibiotic residues in the edible tissue of a dairy cow they sold for slaughter for human food.
The government inspectors found records regarding the sale of the animal during a visit on Aug. 17-18. The cow was sold March 7 and slaughtered the following day. The FDA warning letter states that USDA tests showed the cow’s liver and kidney tissues had 0.3 parts per million (PPM) of the drug sulfadimethoxine, which has a maximum allowable level of 0.1 ppm. The cow also had 0.074 ppm of penicillin in its kidney tissue, well above the allowed 0.05 ppm limit.
“The presence of these drugs in edible tissue from this animal in these amounts causes the food to be adulterated,” according to the Dec. 7 warning letter.
“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to maintain complete treatment records. Your treatment records lack dosage given, route of administration, and withdrawal time for meat and milk.”
The dairy also did not follow label directions when administering the drugs. The cow had received the antibiotics via injection instead of intravenously, as well as receiving more than twice the approved dosage amount for almost three times as long — 13 days instead of 5 days — as directed on the label.
Further, the dairy used the penicillin to combat foot rot, which is not an approved use of the antibiotic. The dairy also admitted to using the antibiotic on lactating cows despite the fact that it is not supposed to be used on female dairy cattle 20 months of age or older.
The dairy was given the standard 15 days to respond to the warning letter. The FDA has not closed the case.
Double Tree Dairy Farm LLC in Holden, UT
The Denver district office of the FDA sent a warning letter Dec. 12 to William H. Wright, owner, regarding the April 6 sale of a dairy cow for slaughter as human food. After slaughter on April 7, the animal was found by USDA testing to have excessive amounts of an antibiotic in its edible tissues.
The cow had 5.25 ppm of desfuroylceftiofur in its kidney tissue. The FDA allows only 0.4 ppm of the drug to be present at the time of slaughter. The FDA also cited the dairy owner for failing to keep records as required by federal law.
“… you failed to maintain complete treatment records and review said records to verify the applicable withdrawal time prior to offering the animal for slaughter as food. Your treatment records lacked information about the dosage given, route of administration, withdrawal time for meat and milk, and individual who administered the drug,” according to the FDA warning letter.
The dairy also failed to observe the minimum required time between administering the antibiotic and slaughtering the cow. Federal law requires a minimum 13-day withdrawal period after the last dose of the drug before an animal can be slaughtered for human food. The cow from Double Tree was slaughtered three days early.
The dairy owner sent a letter to FDA on Oct. 4, promising to do a better job with record keeping, but the agency found that response to be inadequate.
“… you have failed to provide details, dates for implementation, or documented examples for implemented corrective actions, …” the warning letter states.
“We request that you clarify how long you intend to maintain treatment and purchase records, how they will be maintained, and who will be responsible for reviewing such records prior to sending cows for slaughter. In addition, we request that you clarify when your proposed corrective actions will be implemented and what type of information will be included in the treatment records that you define as ‘more complete’.”
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