Category: food safety

Recalls and Alerts: December 26, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

  • Allergy Alert: Haig’s Delicacies (Hayward, CA) recalls Tzatziki (8 oz retail containers & 5-lb bulk foodservice cases) due to undeclared milk, Falafel (5 oz rectangular deli containers & 5-lb bulk foodservice cases) due to undeclared wheat, Spanakopita (bulk foodservice containers) due to undeclared wheat, milk and eggs, and Tyropita (bulk foodservice containers) due to undeclared wheat, milk and eggs. The recalled products were sold nationwide.
  • FDA Warning Letter: FDA warns Sales USA, Inc. (Gladewater, TX) that an August 2012 inspection of the company’s manufacturing facility revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice regulation for food.
  • FDA Warning Letter: FDA warns Seapak O.C.I. (Masset, Canada) that a June 2012 inspection of the company’s seafood processing facility found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns Koon Cheong Lung (Panyu, China) that a July 2012 inspection of the company’s food manufacturing facility found serious violations of the Current Good Manufacturing Practice (cGMP) Regulation for foods and the Seafood HACCP Regulation.
  • FDA Warning Letter: FDA warns Ocean Pier, Inc. (Scoudouc, New Brunswick, Canada) that a June 2012 inspection of the company’s seafood processing facility found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns All American Trading of Houston, Inc. (Houston, TX) that a September 2012 inspection of the company’s seafood distribution establishment found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns Sterling USA Neutraceutical Lab, LLC (Glendale, CA) that a May 2012 inspection of the company’s dietary supplement manufacturing facility found significant violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
  • FDA Warning Letter: FDA warns GM Manufacturing, Inc. (Gardena, CA) that a January-February 2012 inspection of the company’s dietary supplement manufacturing facility found significant violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements.

Canada

Europe

  • Food Safety Recall (Switzerland): Coop recalls Bio Nussbrot/Organic Nut Bread (400g; Product code 7610846856667), Bio Buurebrot/Organic Buurebrot (450g; Product code 7611654685142) and St. Gallen halbweiss/St. Gallen Half white (500g; Product code 7610800647119), because the breads may contain very small aluminum particles. The affected loaves of bread were sold before 10:00 am on December 21, 2012 in affected Coop stores in Northwest Switzerland (Aargau, Basel-Land, Basel-Stadt and Solothum).

Asia, Africa and the Pacific Islands

  • Outbreak Alert (Taiwan): The China Post reports that health experts have recorded an unusually high number of norovirus-related diarrhea cases so far this winter. The tally of 10,108 reports of watery diarrhea at emergency departments last week was a five-year high.
  • Food Safety Enforcement (Abu Dhabi): The Abu Dhabi Food Control Authority has closed down the Musaffah Electrical Bakery (License No. 1038138) due to repeated non-compliance with food safety rules and regulations.

Australia and New Zealand

  • Pharmaceutical Product Safety Recall (Australia): GlaxoSmithKline and Alphapharm recall Ventolin Inhalers (Batch Numbers KN7170, KN7173, KN7178, and KN7179) and Asmol Inhalers (Batch Numbers KL6790, KL6795, KL6796, KL6797, KL6798, and KL6799) due to a fault in the delivery mechanism of a small number of inhalers that can lead to less than a full dose being delivered for each puff. The inhalers are used to treat asthma or chronic obstructive pulmonary disease. To find the batch number of your inhaler, remove the canister from the coloured tube and read the bottom of the canister label.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

USDA Embraces ‘Hold and Test’ For Meat and Poultry Products

Beginning 60 days from now, USDA’s Food Safety and Inspection Service (FSIS) will require producers and importers of raw beef – and of all ready-to-eat products containing meat or poultry – to hold these products until they pass FSIS tests for adulterants.

Products affected by this new policy will not be permitted to enter commerce until negative test results are received. FSIS estimates that, had this policy been in place between 2007 and 2010, 49 out of 251 recalls of meat, poultry and processed egg products could have been avoided. Based on the information contained in the FSIS Recall Archive and list of Current Recalls, the new ‘hold and test’ policy could have prevented the recall of more than 200 tons of meat, poultry and processed egg products in 2011, and more than 175 tons in 2012.

Although finished product testing is not, of itself, a guarantee of food safety, any reduction in the quantity of pathogen-contaminated or adulterated food in the marketplace also reduces the risk of food-borne illnesses. There are, in addition, economic benefits to a ‘hold and test’ policy, including a reduction in the expenses associated with recalls. Not the least of these expenses is the effect of a major recall on the image of the recalling company.

‘Hold and test’ is a sensible policy that should be part of every company’s food safety program. Are you listening, Unilever? Are you listening, Spence & Co.? Are you listening, Kenny’s Farmhouse Cheese? Are you listening, J.M. Smucker?

Are YOU listening, FDA?

Sunland Knowingly Shipped Contaminated Peanut Butter

“Since 2009, your firm has distributed lots of peanut butter and nut butters that were positive for Salmonella. The following is a list of products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm’s internal testing program, and were at least partially distributed by your firm.”

– FDA Form 483, issued October 29, 2012

It’s Peanut Corporation of America all over again.

Earlier today, FDA released a series of Enterprise Inspection Reports and Form 483 reports issued following inspections of Sunland Inc.‘s production facilities in Portales, New Mexico from as long ago as 2007.

The company, whose peanut butter was definitively linked to an outbreak of Salmonella Bredeney that sickened at least 41 people from 20 states, has known about its Salmonella contamination problems since at least June 2009. Somehow, this information escaped the notice of the company’s customers – including Trader Joe’s –  its third party auditors, and FDA inspectors for more than 2 years.

According to company records reviewed by FDA, Sunland found Salmonella contamination in its nut butters (peanut and almond) on more than 20 occasions, including findings of Salmonella Newport in 2009, Salmonella Dallgow in 2010, Salmonella Dallgow, Salmonella Arapahoe, Salmonella Teddington, Salmonella Cerro, Salmonella Mbandaka and Salmonella Kubacha in 2011, and Salmonella Bredeney and Salmonella Meleagridis in 2012.

FDA’s own in-depth inspection – carried out in September and October 2012 after epidemiologists pointed to Sunland’s peanut butter as the likely source of an outbreak of Salmonella Bredeney – found Salmonella Bredeney in samples of peanut butter, as well as Salmonella Senftenberg, Salmonella Montevideo, Salmonella Bredeney, Salmonella Mbandaka, Salmonella Meleagridis, and Salmonella Anatum in the production plant environment.

That’s more strains of Salmonella than many labs maintain in their reference collection!

In addition to turning a blind eye to the contamination that pervaded its operations since 2009, Sunland’s management ignored standard Good Manufacturing Practices, as evidenced by the following litany of “Observations” reported by FDA in October 2012:

Observation 1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Observation 2: Failure to handle equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

  • Specifically, the production and packaging lines of equipment in the Peanut Butter Plant were not cleaned after each time Salmonella was isolated from peanut and nut butter products between 2009 and 2012.
  • The … packaging equipment in the small packaging room of the Peanut Plant is not effectively cleaned between raw and roasted peanuts. Cleaning consists of wiping off non-food contact surfaces with dry paper towels, sweeping underneath and around equipment, as well as vacuuming excess dust.
  • Tote mesh bags utilized by your firm for storing bulk peanuts are not effectively cleaned between storage o f raw and treated (roasted and/or brined) peanuts. The tote bags are considered multi-use, and re-used for both raw and roasted peanuts.
  • Firm does  not clean production and packaging equipment between runs of various allergen-containing products.

Observation 3: Food contact surfaces used for manufacturing low-moisture food were wet at time of use.

Observation 4: The design and workmanship of equipment does not allow proper cleaning.

Observation 5: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt, and organic matter and the opportunity for growth of microorganisms.

Observation 6: Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.

Observation 7: Plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant.

Observation 8: The plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair.

Observation 9: Failure to store raw materials in a manner that protects against contamination.

  • From 9/17112-10/2112, raw, in-shell peanuts were observed outside in uncovered trailers and open to the elements. Birds too numerous to count were observed flying over, and landing on peanuts in the trailers.
  • On 9/28/12, [FDA inspectors] observed the weather as overcast and rainy, seven open trailers filled with peanuts were observed stored uncovered on the front of [the] property exposed to moisture from the weather.

Observation 10: Effective measures are not being taken to exclude pests from the processing areas.

As for the company’s compliance history, consider the following:

In 2003, FDA cited the following problems: (1) the firm’s plumbing constitutes a source of contamination to food; (2) effective measures were not being taken to protect against the contamination of food on the premises by pests; (3) the firm failed to provide adequate screening or other protection against pests; (4) the firm failed to hold rework materials in bulk or in suitable containers so as to protect against contamination; and (5) the firm failed to maintain the buildings in repair sufficient to prevent food from becoming adulterated.

In 2007, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination; (2) the firm failed to take reasonable precautions to ensure that production procedures do not contribute contamination from any source; (3) employees were observed not washing and sanitizing hands thoroughly in an adequate hand washing facility before starting work and after each absence from the work station; (4) effective measures were not being taken by the firm to protect against the contamination of food on the premises by pest (a repeat observation); (5) the firm failed to store raw materials in a manner that protects against contamination; and (6) the firm failed to maintain buildings in repair sufficient to prevent food from becoming adulterated (a repeat observation).

In 2009, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential of microorganisms and contamination (a repeat observation); (2) the firm failed to take all reasonable precautions to ensure that production procedures did not contribute contamination from any source (a repeat observation); (3) failure to take all reasonable measures and precautions to ensure personnel cleanliness by utilizing effective hair restraints and ensuring that beard covers were worn in an effective manner; (4) failure to ensure employees washed/sanitized their hands properly when returning from the work station (a repeat observation); (5) failure to maintain equipment used to hold food ingredients in a manner that protects them from contamination. Also, FDA found Salmonella in an environmental sample taken during its 2009 inspection.

In 2010, FDA cited the following problems: (1) All reasonable precautions are not taken to ensure that production · procedures do not contribute contamination from any source; (2) Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests; (3) The plant is not constructed in such a manner as to allow floors to be kept in good repair; (4) Failure to wear beard covers in an effective manner; (5) The design and construction of equipment and utensils fails to preclude the adulteration of food with contaminants.

In 2011, FDA cited the following problems: (1) Failure to store raw materials in a manner that protects against contamination; (2) Failure to provide adequate screening or other protection against pests.

Am I the only one who doesn’t understand what’s going on here?

Where were the company’s customers? Did they never visit the production plant?

Where was Silliker Laboratories, the company’s third party auditor? Did they ever visit the production plant or review the company’s internal lab results?

AND WHERE THE HELL WAS FDA? Why did the agency not review Sunland’s internal lab results and production/distribution records until after the company’s negligence resulted in a food poisoning outbreak?

If this is an example of “Food Safety Modernization” in action, please give me the Good Old Days.