FDA Warning Letter Issued to MA Bakery for Being Nasty

FDA issued a Warning Letter to a Massachusetts bakery, a manufacture of Peggy Lawton Ready-to-Eat (RTE) bakery products, including cookies and brownies.  It seems like this operation checked all the boxes on inspection sheet.  This operation has been operating for over 60 years doing it they way they have always done it.  A write-up in the Boston Globe discusses the company and their success and challenges.  It can be guessed that because they do not sell into larger chains, there was probably never a third party audit conducted.  Keeping low key has allowed them to stay under the radar...unfortunately for their customers.

"FDA determined that "the RTE food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC 331(uu)]."

• No Preventive Control Plan 
• Potentially contaminating product with raw flour (which we know can contain Salmonella) -  empty bags of raw flour were observed placed over racks of ready-to-eat brownies and in direct contact with the pans of cooling brownies
• Improper maintenance - tape is not acceptable for fixes - multiple layers of electrical tape were observed wrapped around a cookie die. The cookie dough is pressed out of the die to make dough in the shape of cookies.
• Improper surfaces for holding RTE product - ready-to-eat brownies were observed placed onto mats prior to being sliced. Areas of the mats appeared to be porous, and the ends of the mats were frayed.
• Unsanitary cleaning equipment - a wire brush duct taped to a wooden pole was observed being used to remove cookie crumbs from the chain conveyor located before the first cooling tunnel. The duct tape was frayed, and there was as an accumulation of apparent food residue on the handle of the wire brush and duct tape and on the bristles of the wire brush.
• Inadequately cleaned transfer containers -  the gray totes used for holding brownie scraps were observed to have an accumulation of apparent food residue on the inside of the tote that comes into direct contact with the brownie scraps that are used to manufacture brownies.
• Non-approved sanitation chemicals and poor cleaning practices- the agent used for cleaning and sanitizing food contact surfaces consists (b)(4), Production employees were observed using this mixture of (b)(4) to wipe down food contact equipment including brownie mats, round blades for slicing brownies, brownie packing line conveyor belts, and the conveyor belts on the cookie line.
• Backflow devices needed on hoses - a hose at a two-bay sink was connected to a drum containing floor cleaner. The hose was equipped with a shut off valve where the hose connects to the drum. The hose lacked an appropriate backflow prevention device.
• Inadequate hand washing stations -  the hand washing sinks located in the cookie packing room were observed to not be operating from May 28, 2019 – May 30, 2019. Additionally, the sink located in the ingredient prep area and the sink located between the dishwasher and floor cleaner dispenser were not equipped with hand sanitizer.
• Unsanitary employee clothing - an employee working in the brownie mixing area was observed to have heavily soiled pants at the beginning of the production day (approximately 5:35 AM) and the employee’s clothing became increasingly more soiled throughout the work day. The employee's soiled pants were observed coming into direct contact with the edge of the depositor hopper each time they leaned over the brownie depositor hopper as they scraped the contents of the brownie batter mixing bowl into the depositor hopper.
• Improper sanitation procedures - the equipment used to manufacture brownie batter was cleaned with water only; the cleaning did not include the use of detergent, physical scrubbing, and a sanitizer.
• Potential cross contamination issues - an employee was observed removing sheet pans of cooked brownies and placing them on a rack immediately beneath sheets pans of uncooked brownies. Additionally, your firm uses the same oven racks for holding sheet pans of uncooked brownies prior to placing the sheet pans in the oven and for holding pans of cooked brownies after they are baked. The brownie racks, which are not placed in the oven, are cleaned every (b)(4) to (b)(4) and were observed to be soiled with apparent uncooked brownie batter and cooked brownie particles.
• Improper dishwasher usage - the dishwasher is loaded along with water and detergent at the beginning of the day. This water/detergent mixture is recycled all day and is not discharged until the end of the day. Additionally, the dishwasher does not utilize a chemical sanitizing agent. The highest temperature achieved during a complete wash cycle according to the temperature monitoring probe on the dishwasher was observed to be 142 °F.
• Inadequate hand washing by employees - numerous occasions identified where employees did not wash their hands as they should have. (see item #9)
• Probable allergen cross contact - the last batch of cookies manufactured on May 28, 2019, consisted of Chocolate Chip Cookies (which contain walnuts), and the first batch of cookies manufactured on the same equipment on May 30, 2019 (the next day of manufacturing), were Oatmeal Cookies (which do not contain walnuts). The equipment was inspected at the end of the day on May 28, 2019, but on May 30, 2019, prior to manufacturing the Oatmeal Cookies, cookie and cookie residue were observed on the chain conveyors, turn tables, cookie magazines, and cookie chutes. You stated the last time the conveyors were cleaned was January 2019.
• Improper bulk storage with the potential for contamination -  an exposed bulk size (b)(4) was observed stored on top of unopened cardboard boxes (b)(4).
• Floors inadequately cleaned and maintained - The flooring near the brownie mixing station and brownie oven was observed to have an accumulation of apparent food residue and grime after cleaning was conducted on May 29, 2019. Additionally, floor tiles were observed in disrepair with an accumulation of apparent food residue and grime in the production area.
• Standing water, a big no-no in dry operations due to microbial proliferation - Water was observed pooling over the floor drain where brownie packing operations are conducted and where employees stand and walk when packaging brownies. Additionally, pooling water was observed in an area along the wall near the shortening dispenser in the brownie batter prep area. 
• Rust and flaking paint - Paint was observed to be peeling and chipping along the wall behind the flour sifter where opened buckets of flour were held.  And the door frames to the humidifier tunnel contained apparent rust and flaking paint.
• No training records - did not have records documenting training in the principles of food hygiene and food safety for employees who manufacture, process, pack, or hold brownies

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peggy-lawton-kitchens-inc-586321-08292019

WARNING LETTER

Peggy Lawton Kitchens, Inc.
MARCS-CMS 586321 — 

August 29, 2019

Imported Spice Packets Recalled After FDA Sampling Finds Salmonella

House of Spices, an Indian food specialty company, is recalling its Sambar Masala spice after FDA had tested and found that the product was positive for Salmonella.  Based on the picture of the packaged which was posted on the FDA website, the product was sourced from the Middle East.

As part of the requirements, the importer of this product, House of Spices, would have been required to have a FSVP, or Foreign Supplier Verification Program in place, and as part of that program, measures in place to ensure that the supplier of this product had controls for hazards.   And with spices, Salmonella would be a potential hazard.  These measures could include:

• requiring a COA for each lot with sampling and testing from a reputable laboratory, 
• an onsite audit to ensure that 1) spices are being properly treated and 2) the facility had controls to protect against environmental contamination in mixing and packing areas
• the importers own testing protocol which would check incoming lots and serve as a verification of the COA.  One would be looking at large sample quantities (375 g rather than 25g) over multiple units within the lot. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/house-spices-india-issues-recall-mdh-sambar-masala-due-salmonella-contamination
House Of Spices (India) Issues Recall of "MDH Sambar Masala" Due To Salmonella Contamination
Summary
Company Announcement Date: September 07, 2019 

FDA Publish Date:September 07, 2019 

Product Type: Food & Beverages 

Reason for Announcement: Salmonella
Company Name: House Of Spices India 

Brand Name: MDH
Product Description:  MDH SAMBAR MASALA

Hamburger Buns Recalled After Dough Scrapper Gets 'Incorporated' into Dough

Conagra Brands is voluntarily recalling approx. 2,200 cases of Udi’s Classic Hamburger Buns due to the potential presence of small pieces of white plastic. "The company discovered the issue which occurred when a dough scraper was inadvertently incorporated into the production process for a small amount of the product."  'Inadvertently incorporated' could mean accidently dropped, left in mixer after use, etc.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/udis-classic-hamburger-buns-recalled-due-potential-presence-foreign-material
Udi’s Classic Hamburger Buns Recalled due to Potential Presence of Foreign Material
Summary
Company Announcement Date: September 06, 2019
FDA Publish Date: September 06, 2019
Product Type: Food & Beverages
Reason for Announcement: Foreign Object White Plastic
Company Name:Conagra Brands
Brand Name: Udi's
Product Description:  Classic Hamburger Buns

Woman Suffers Severe Injury from Pressure Cooker

An Indian woman suffered a severe injury as the whistle (or pressure relief) from a pressure cooker shot off the canner into her eye and lodged into her scull.

These issues are rare, but serves as a reminder for those using pressure cookers or canners to pay attention when heating under pressure to prevent excess pressure from building up in the canner.  In this case, the woman was doing something else and had ignored the whistling sound generated by the canner and then tried to move the canner rather than just turning off the heat.

Other important measures to take..make sure your canner is clean and in good working condition, including the pressure canner/cooker pressure relief/whistler/giggler value is free of build up and the pressure monitoring gauge is working.  Be sure pressures are within the range called for in the recipe, and take corrective action such as reducing heat if the pressure goes a few pounds above that pressure.  If excessive pressures are reached, turn off the heat completely, and stay away from unit until pressure dissipates.

Fox News
https://www.foxnews.com/health/pressure-cooker-whistle-skull
Pressure cooker whistle shoots off, lodges into woman's skull
By Madeline Farber | Fox News
9/9/19

FDA Issues Consumer Advisory on Yellowfish Tuna Steaks Purchased from Kroger

FDA issued an alert on yellowfin tuna steaks sold through Kroger retail stores.  The issue is the potential for high histamine levels which cause scombroid poisoning.  The high histamine levels occur when the fish had been temperature abused, and when that occurs, spoilage microbes convert the amino acid histidine, which is present as part of the fish protein, to histamine.

"Scombroid symptoms usually develop within a few minutes to an hour after eating contaminated fish. They usually resemble an allergic reaction, such as flushing of the face, headache, heart palpitations, itching, blurred vision, cramps, and diarrhea. Symptoms can be treated with antihistamines. Even without treatment, people usually get better within 12 hours."

According to the report, "FDA became aware of multiple scombroid poisoning cases in individuals who consumed tuna steaks purchased from three separate Kroger retail locations in Ohio."

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-consumers-not-eat-yellowfin-tuna-steaks-kroger-retail-stores-multiple-states
FDA Advises Consumers Not to Eat Yellowfin Tuna Steaks from Kroger Retail Stores in Multiple States
September 7, 2019

E. coli Outbreak in Philadelphia Affects 14, Source Not Yet Identified

Philadelphia health officials report an outbreak of E.coli that has affected 14, with ages ranging form 7 to 90.  While it is believed it is a 'shared restaurant exposure", no restaurant has been yet identified.

Update 9/9/2019 - 16 cases now reported. Link

Philadelphia Enquirer
https://www.inquirer.com/health/e-coli-outbreak-philadelphia-diarrhea-kidney-failure-food-20190905.html
Philadelphia officials issue health alert over E. coli outbreak
by Rita Giordano, Updated: September 5, 2019

The Philadelphia Department of Public Health on Thursday announced an outbreak of E. coli infections that has sickened 14 people so far.

This Week in Allergen Related Recalls for Week Ending September 7, 2019

Egg Not on Label - Great One Trading Inc. is recalling the above because it may contain undeclared egg. The recall was initiated after it was discovered that the product containing egg was not revealed on the packaging. Subsequent investigation indicates the problem was caused by a mislabeling error by the manufacturer.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/great-one-trading-inc-issues-expanding-allergy-alert-undeclared-egg-fishball-products
Great One Trading Inc. Issues Expanding Allergy Alert on Undeclared Egg In Fishball Products
Summary
Company Announcement Date: September 04, 2019
FDA Publish Date:September 04, 2019
Product Type: Food & Beverages Fish
Reason for Announcement: Undeclared Egg
Company Name:Great One Trading Inc.
Brand Name: QQ Fish
Product Description: Fish Ball Products

The Story of Six Sigma Quality Management System

There is an interesting article in Quartz on Six Sigma, the quality management system championed by General Electric. It details how a tool for improving manufacturing precision and efficiency expanded to become guiding principle applied to all aspects of the company.  Employees worked to become green belts and then master black belts, designations for practitioners of Six Sigma.  In time however, GE's fortunes dropped from the high flyer of the 1990's, and with that, Six Sigma lost its luster.

GE was not the only company as many companies including a good number of food companies looked to have Six Sigma trained professionals in key positions.  As a technical professional, I had considered such training.  However, it was time consuming, costly, and difficult to justify.  Not to say these tools and concepts were not beneficial, but basic training in statistical process control and process improvement was sufficient for most applications.

It is not too far back in time when these tools were absolutely needed.  A good example was the US automobile industry of the 1970s and early 80s...you'd be lucky if a new car lasted 5 years without extensive repairs.  For food operations, process efficiency and waste were a major concern.  Now, measurement of many of these factors are automatically measured and controlled...items such as equipment downtime/uptime, fill weight, percent defective, etc.  Still, it is important for employees to understand these concepts and how to apply them in food manufacturing operations.

An important point to recognize is that this is a tool, but when that tool become the overall strategy or when leaders become overly obsessive in its use, then there can be ramifications.  In this case, as pointed out in the article, the company's focus did not support innovation and risk taking.

Quartz at Work
https://qz.com/work/1635960/whatever-happened-to-six-sigma/
DEEP SIXED
Whatever happened to Six Sigma?
By Oliver Staley6 hours ago

Modernizing the Standards of Identity - Names Should Mean Something

Is soy milk really milk?  This is one of a number of food questions that are likely to come up in FDA's upcoming public meeting on the modernizing the Food Standards of Identity.

While to most, the food standards of identity are not an overly exciting topic, but they do serve a purpose in establishing what defines a specific product.  "These regulatory standards specify the characteristics of hundreds of different foods, everything from frozen cherry pie to milk, but critics say many of these definitions are in desperate need of an update, including a definition of milk that specifies that the beverage come from a lactating animal." 

In recent times, there have been a number of  new-to-us type of products entering the marketplace, and they take on familiar names, because it is just easy to assign a name that customers are familiar with.  But is that right?  Sure we know soy milk is not really milk, but do we make assumptions about aht product, perhaps it has the same nutritional value of milk.  What about the producers of regular milk, should they not have some protections against infringement on what they make?  

And perhaps for soy milk, consumer understand that it is different, but will that always be the case?  I am one for having a name mean something.  If it is not the same, then call it something different.  And if it has that name, then there should be certain expectations for what that item is.  

FORBES
https://www.forbes.com/sites/jennysplitter/2019/09/05/food-label-redux-fda-to-hold-public-meeting-on-food-standards-of-identity/#40e824187599
Got Food Label Confusion? FDA To Hold Public Meeting On Food Standards Of Identity
Jenny Splitter
Sep 5, 2019, 09:06am