FDA Warning Letter - Bakery with 'Love' Listed in Ingredient Statement - Nasty Food Operations Exposed

A MA bakery received a Warning Letter from FDA.  While the bakery violated most all basic GMPs, the one item that has caught the eye of the press is the fact the the company listed 'love' as an ingredient.  "Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1). "Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."  But this was just a minor issue compared to the vast array of GMP violations.  That is, unless they refer to nastiness as 'love',..,..then there was plenty.

Now, if I am overseeing a bread operation, and seeing this as well as this Warning Letter in August for a NM bakery, I am getting a sense that FDA will probably be looking at bakeries a little more critically than they have in the past, and thus, it may be time to tighten up the ship a bit more.

There were a ton of issues, but as a sampling:

• Food residue on equipment that was stated as being clean and sanitized including "empty color-coded barrels designated for use with different allergens including tree nuts and cheese with apparent dough residue inside and out, and stacked inside one another."  It was stated that the "firm does not have a procedure or production schedule to ensure cleaning and sanitation is done before production or in between changes to prevent cross-contamination of different allergen products."
• Failed to maintain equipment and utensils and finished product containers in an acceptable condition through appropriate cleaning and sanitizing  - bread residues on screens, totes, etc.
• failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition - ceilings, air intakes etc coated with stuff.
• Failed to ensure equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination
• failed to provide, where necessary, adequate screening or other protection against pests - flies and crawing bug in processing area.
• Personnel not following basic GMPs. - wearing jewelry, eating in operational areas.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577393.htm
Office of Human and Animal Food Operations East
Division 1

WARNING LETTER
CMS# 532236

Nashoba Brook Bakery, LLC 9/22/17
September 22, 2017

Auditor General - FDA Follow-up to Inspections Found to Be Slow and Lacking

In a report by the Auditor General to the FDA, there was criticism that FDA was not taking enough action fast enough.  "Auditors examined data from 2011 to 2015 and determined the agency was on pace to conduct the required inspections, but hadn’t made sure that all problems were corrected."  In defense, many of the inspections that were longer in response were for dietary supplements - the wild west of FDA's regulatory world.  And with new regulations just coming upon implementation date, there is a huge gap in knowledge for both the firms and the inspectors.

• In the time frame analyzed, inspectors found significant dificiences in 1245 establishments.
• While some type of actions was taken in 78% of the inspctions, in 22% nothing was done.
• "Almost half of the warning letters were sent after the agency’s goal of four months [which is still a long time]. Twenty percent were sent after more than six months, and 2 percent were sent more than a year after the inspection."
• "The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years."
• "Of 766 facilities that received “advisory” actions, about 1 in 5 were found to have significant violations on follow-up inspections. In about three-quarters of them, the violations were identical to those previously discovered."

The Morning Call (Allentown, PA)

http://www.mcall.com/news/watchdog/mc-nws-food-safety-inspection-problems-watchdog-20171003-story.html
Food safety oversight not well done
by Paul Muschick•Contact Reporter
The Watchdog
October 4, 2017, 8:55 PM

FDA - Impact of Gluten Free Labeling Standard

From the FDA website, a conversation about the impact of the gluten free labeling standard.  Three years ago, FDA rolled out what it means for a label to say "Gluten Free".  In short, it must have less than 20 PPM of gluten.  Overall, it has been successful in helping people with celiac disease - a serious ailment that damages the lining of the small intestine gut that prevents the body from absorbing nutrients.

FDA has been conducting testing on products labeled "Gluten Free".  "Earlier this year we released the results of a sampling assignment in which 702 samples from more than 250 products labeled “gluten-free” were analyzed. Only one of those products did not comply with our labeling requirements."  FDA plans to continue testing.

FDA Website
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm577489.htm
Updated 10/04/17
Three Years Later, What is the Impact of the Gluten-Free Labeling Standard?

A NC Establishment Recalls Ground Turkey for Foreign Material - Metal Fragments

A N.C. establishment, is recalling approximately 38,475 pounds of ground turkey that may be contaminated with extraneous materials.  The problem was discovered on September 27, 2017, when FSIS was notified by plant employees performing sanitation on processing equipment. On the same day, one of the retail locations involved noticed metal shaving in a package of ground turkey from the recalling firm, and notified the company.  Good job to these sanitation guys for catching this!

USDA Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-104-2017-release
Prestage Foods, Inc. Recalls Turkey Products Due To Possible Extraneous Material Contamination
Class II Recall 104-2017
Health Risk: Low 

Oct 2, 2017

PA Establishment Recalls Ground Beef for E. coli O157:H7

A PA establishment is recalling approximately 700 pounds of ground beef products that may be contaminated with E. coli O157:H7.  "The problem was discovered on Oct. 2, 2017 when the firm notified FSIS that the firm’s sample of ground beef had tested positive for E. coli O157:H7 by a third party lab. There have been no confirmed reports of adverse reactions due to consumption of these products."

Yes, this organism is still a risk in ground beef with dire consequences for those who become infected from eating undercooked contaminated hamburgers.  A reminder to use those thermometers.

USDA Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-106-2017-release
Clair D. Thompson & Sons, Inc. Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
Class I Recall 106-2017
Health Risk: High Oct 4, 2017

Puppy Related Campylobacter Outbreak Now Reaches 55 Cases

There are now 55 cases of Campylobacter linked to puppies sold through a Ohio pet store.  The recall was first announced by CDC on September 11th. .  Isolates were taken from stool samples from ill puppies closely matched those of ill individuals.  Isolates were also tested for antibiotic resistance and all 13 of Campylobacter isolates tested were shown to be antibiotic resistant to first line antibiotics.

https://www.cdc.gov/campylobacter/outbreaks/puppies-9-17/index.html
Multistate Outbreak of Human Campylobacter Infections Linked to Pet Store Puppies
Posted October 3, 2017 2:00 PM ET

Egg and Ham Salad Sandwiches Recalled for Potential Listeria Contamination

The US affiliate of Greencore, an international company specializing in making ready made sandwiches, is recalling Egg Salad and Ham Salad sandwiches and Seafood Stuffing after FDA samples and found Listeria in the food processing environment.    The product was distributed in Northeast US

It was not stated where in the facility the samples were found, but one would expect that it was in an area that implicated the potential for product contamination.

https://www.fda.gov/Safety/Recalls/ucm578325.htm
Greencore USA, LLC Recalls Egg Salad Sandwiches, Ham Salad Sandwiches, and Seafood Stuffing Because of Possible Health Risk
For Immediate Release
September 29, 2017

This Week in Mislabeled Product - ending 9/29/17

A WI firm is voluntarily recalling Waterfront Bistro Tartar Sauce because there is a chance an incorrect back label was attached to the product, which does not correctly identify ingredients that could pose an allergen risk; specifically egg.  From the notice - "The recall was initiated after production checks at our manufacturing facility found the incorrect back label for Hot Cocktail Sauce instead of Tartar Sauce.  ....... The defect identified was caused by a temporary breakdown in our label supplier’s production and quality control processes."

An Illinois establishment is recalling an undetermined amount of smoked turkey products due to misbranding and undeclared allergens - the products contain milk, a known allergen, which is not declared on the product label. The problem was discovered by FSIS Inspection Program Personnel while performing routine label verification checks.

A NY firm is recalling its VINA CAFÉ WAKE-UP INSTANT COFFEE MIX in 18 PACK CARDBOARD BOXES (.6 oz packs), with lot “EXP:17.MAR.2019 1T13.” because they contain undeclared milk allergens.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 0.6 ounce plastic package, with 18 packets per cardboard box of VINA CAFÉ WAKE-UP INSTANT COFFEE MIX which did not declare a milk ingredient on the label.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm577561.htm
Silver Spring Foods, Inc. Voluntarily Recalling Waterfront Bistro Tartar Sauce Due To Possible Mislabeling and Undeclared Allergen
For Immediate Release
September 26, 2017

CDC MMWR - 2016 Outbreak of Campylobacter Linked to Undercooked Chicken Liver Mousse

In a 2016 case, 4 people became ill from Campylobacter after eating undercooked chicken liver mousse.  From the report, "During an inspection on July 15, the sous-chef solely responsible for preparing the chicken liver mousse demonstrated preparation to the CCPH food safety inspector, who observed that the sous-chef used the appearance of the livers alone to determine whether they were fully cooked. Final internal cook temperature of the largest liver measured by the inspector was <130°F (54°C), below the minimum 165°F (74°C) internal temperature deemed necessary by the Food and Drug Administration to eliminate food safety hazards"

Campylobacter is naturally found in chickens and is a risk for causing foodborne illness when there are cross contamination issues or undercooking.
CDC - MMWR
https://www.cdc.gov/mmwr/volumes/66/wr/mm6638a4.htm?s_cid=mm6638a4_e
Notes from the Field: Outbreak of Campylobacter jejuni Associated with Consuming Undercooked Chicken Liver Mousse — Clark County, Washington, 2016
Weekly / September 29, 2017 / 66(38);1027
Derel Glashower, MPH1; Jennifer Snyder1; Diane Welch, MS1; Shannon McCarthy1 (View author affiliations)
View suggested citation