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More Clues to May and July Fresh Express Recalls

Fresh Express, the nation’s dominant bagged salad producer, needs to review its criteria for receipt of raw products, according to the U.S. Food and Drug Administration (FDA) .

In an Oct. 6 warning letter to Fernando Aguirre, president and chief executive officer, of Chiquita Brands International Inc and Fresh Express Inc., FDA added more details about two recalls of romaine lettuce earlier this year.

FDA said the two Fresh Express recalls—May 24 for Salmonella and July 13 for E. coli O157:H7–both stemmed from samples of fresh express products obtained by an agency contractor at the retail level.

“We also note that, FDA (through its contractor) obtained two samples of Fresh Express Hearts of Romaine, the testing of which yielded human pathogens,” the warning letter said.

“One sample was found to contain Salmonella Anatum; another sample was found to contain E. coli O157:H7,” it continued.  “We acknowledge that you issued letters to your customers in an effort to recall the affected products.”

“However, FDA recommends that you review your firm’s criteria for receipt of raw product, your procedures for ensuring that wash, flume and processing water do not contaminate your products and other conditions and practices that may be related to the cause of the contamination.”

In addition to writing their customers, Fresh Express went public with both recalls.  They were subject of widespread publicity.

In its Form 483 report with inspection observations, FDA cited Fresh Express with violations of the Good Manufacturing Practices.  In the warning letter, FDA said Fresh Express has since agreed to:

-Retrain employees to replace or sanitize their gloves after contacting unsanitized surfaces.

-Include the dryer hoist controls and equipment control panels that involved direct employee contact in daily wash and sanitation procedures.

-Create a new storage system for aprons, gloves, and sleeve guards for times during manufacturing when they are not in use.

-Modify cutting surface inspection and replacement programs so that cutting surfaces will be changed after a certain amount of use.  

FDA wants Fresh Express to provide documentation that these changes have been made.   It also wants Fresh Express to address the Form 483 observation that its technician improperly read the free chlorine indicator in tests of flume water.

No infections or illnesses have been associated with either of the romaine lettuce recalls, and there is nothing in the warning letter to indicate more specifically how the contamination occurred.

In the warning letter, FDA also accuses Chiquita of “misbranding” its “Pineapple Bites” and “Pineapple Bites with Coconut” products.  One is made with a coconut flavor spray, not real coconuts.

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