Trade Resources Economy The U.S. Food and Drug Administration Issued 11 Warning Letters

The U.S. Food and Drug Administration Issued 11 Warning Letters

Tags: FDA, FOOD SAFETY

In the first month of 2014, the U.S. Food and Drug Administration issued 11 warning letters to food manufacturers and processors. The first two warning letters of the year were delivered to a seafood processing facility in Hawaii and a dairy operator in Pennsylvania.

January saw nine more warning letters issued to a variety of businesses.

Dairies Warned For Improper Drug Use

Three more dairies received warning letters after selling cows for slaughter who were considered adulterated by FDA. Tissue samples collected from slaughtered animals sold by these dairies tested positive for unacceptable levels of drug residues.

The letters referenced findings of investigations conducted at each facility in 2013.

"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," FDA District Directors from Detroit, Baltimore and Minneapolis wrote in warning letters addressed to Parisville Dairy of Cass City, MI, Shank Farms of Hagerstown, MD, and Wild Rose Dairy of LaFarge, WI.

The FDA District Directors requested written responses detailing steps taken to bring the firms into compliance with food safety laws and regulations, to correct violations cited in the letters and to prevent their recurrence.

Egg Producers Warned For Failure to Prevent Salmonella Enteritidis, Pests in Plants

Two egg production facilities also received FDA warning letters in January. Both were cited for violations of regulations designed to prevent Salmonella enteritidis in shell eggs and for improper pest monitoring.

Jeffrey Mlsna of Cashton, WI, and Elmer Yoder of Lockridge, IA, received the letters from FDA District Directors in Minneapolis and Kansas City, respectively. Each egg producer has 15 working days from the receipt of the letter to notify FDA of specific steps that have been taken to correct the violations and prevent their recurrence.

Seafood Processors Warned for HACCP Violations

Foreign seafood processors from Hong Kong and India received warning letters for violations of Seafood Hazard Analysis and Critical and Control Point (HACCP) regulations.

Yuet Heung Yuen Sauce Food (Zhuhai) Co. of Hong Kong received a warning letter that cited the company for failure to employ a proper HACCP plan and to properly identify a major food allergen (soy) as a food safety hazard.

Gadre Marine Export of India received a warning letter for failures in its HACCP plan related to the seafood processor's packaging and cooling procedures, in addition to monitoring procedures for critical control points within the facility.

Both seafood processors are required to document specific steps they will take to correct deviations cited by FDA and to come into compliance with applicable laws and regulations. They have 15 working days from receipt of the letters to reply to Charlotte Christin, Acting Director of the Office of Compliance for the Center for Food Safety and Applied Nutrition.

Snack Food Manufacturer and Nut Processor Warned for Manufacturing Practices, Labeling Laws

 

Oskri Corporation of Lake Mills, WI, received a warning letter from the FDA Minneapolis District Director after several inspections conducted in May and June of last year revealed violations of Current Good Manufacturing Practices and food labeling laws.

The snack food manufacturing facility was cited for 13 violations related to improper sanitation, cross-contamination, food-safety procedures and misbranding. Oskri Corporation has 15 working days from receipt of the letter to notify the FDA Minneapolis District Office of steps taken to bring the firm into compliance with food safety laws.

ARO Pistachios of Terra Bella, CA, was issued a warning letter for findings of an FDA inspection at the facility conducted in response to a Salmonella outbreak traced to ARO Pistachios' product in early 2013. ARO Pistachios recalled pistachios in July after the California Department of Health found Salmonella in its product.

The May inspection revealed that in-process pistachios were handled in violation of federal regulations and that ARO Pistachio products "have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health."

ARO Pistachios has 15 working days from receipt of the letter to describe in writing to the FDA Compliance Branch in Alameda, CA, specific steps the company has taken to correct noted violations and prevent the noted violations or similar violations from occurring again.

Source: http://www.foodsafetynews.com/2014/02/9-more-warning-letters-issued-by-fda-in-january/
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FDA Issued 11 Warning Letters in January