A NM Bakery Issued a Warning Letter - Issues with Sanitation and Lack of Management Training

A New Mexico bakery was issued a warning letter from the FDA.  Most of the issues cited involved basic sanitation, and they were issues that were also noted in a 2014 inspection...thus the issuance of the Warning Letter.  To look at the facility from Google Street view (below), it looks like a legit operation (compared to this)

Many bakeries may be new to FDA inspections, although it was noted that this firm had a previous FDA inspection in 2014 (and unfortunately, didn't make much progress from that time...or so it seems).  But one of the items that is most interesting involves training, or the lack of training, specifically of management (see further down).

• Unsanitary condition noted on 1) walls, overhead door, and cooling fan in areas used to cool baked bread., 2) condenser fans and support pole in walk-in refrigerator used to store uncovered apple pies, and 3)  3-Compartment sink used to clean in process equipment.
• Peeling paint in the incoming supply room above ingredient containers which had broken lids, no lids, lids not fully covering materials. Additionally, peeling paint was observed on the ceiling of the walk-in refrigerator used to store uncovered apple pies.  
• Fresh and dried dough on the ceiling above an uncovered mixer and along the rim of the (b)(4) bucket. (b)(4) is used as a processing aid in the production. 
• Condensation issues  with buildup inside the proofing  along the ceiling, sides of walls, and along the door frame. As the uncovered dough enters the  proofing (b)(4), condensation drips directly onto uncovered dough.  Dark brown condensation buildup was observed in the production area on the ceiling above the proofing  and the final bread rolling area.  Condensation buildup was observed in the walk-in freezer fans located above finished product.
• Inadequate screening or other protection against pests - the outer door and warehouse garage doors were open during food production activities without adequate protection to prevent entry of pests into the production facility.
• The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment - the 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. Utensils were then immediately used without allowing them to air dry. At the final dough, recently used trays covered with residue were slammed on the floor to remove particles and then placed onto the cart, without washing, to be reused. Our investigator observed fresh dough immediately placed on these trays and sent to proofing .   In the proof , there is no evidence that the conveyor trays used to transport the dough from the extruder to the are sanitized.  The firm’s water filters have not been changed since 2013. There was dark brown and slimy residue in the filter. The filtered water is used in the production of dough, to clean large pieces of equipment, and used in the 3-compartment sink.

But this is the item to note - "Personnel responsible for identifying sanitation failures and food contamination lack a background of education and experience to provide a needed level of competency as required by 21 CFR 110.10(c). Specifically:

•  The production manager did not know the correct order of operation to properly clean and sanitize utensils at the 3-compartment sink. The 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. During the inspection, the rinse water was observed to be cloudy and dirty, providing a possible source of cross-contamination.
• The production manager did not know what the adequate sanitizer concentration should be; there were no test strips available to verify the concentration, and he relied solely on placing one capful of bleach into water
• The president of the company lacks basic sanitation knowledge. For example, when asked about the sanitation procedures, he commented on cleaning the floors and was not aware of equipment cleaning and maintenance schedules. He also did not know the required sanitizer concentration and did not provide test strips to employees for verification."

As we know, as part of 21CFR117, it is required that management be adequately trained in food safety.

Finally - the firm failed to provide appropriate training in food handling techniques and food protection principles have not been provided to food handlers 1) an employee touching ready to eat bread rolls with bare hands to determine if they were cool enough for packaging. 2) an employee in the packaging area wearing only one glove, on the right hand. The employee was manually sorting bread into final packaging with both the gloved and bare hands.

FDA Recall Notice
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm570807.htm
July 5, 2017
WARNING LETTER
Brent A. Bischoff
President
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301

Virginia Peanut Company Issued Warning Letter - A Cat for Pest Control? The Risks of Ordering Food Online

FDA issued a warning letter to a Virginia peanut products company.    A summary of the key findings:

• A cat as pest control.  And cat feces in the facility.
• Sliding doors not sealed providing an opening to the outside
• Employees not properly washing hands
• Employees using tobacco in food contact areas
• Food residues left on equipment
• Old, unused equipment stored throughout facility
• Air flow blowing peanut dust around.
• Employees not wearing hair restraints.
• Labeling issues involving nutrient claims, ingredient statements, and company listing.

It seems that they sell products online, and looking at their website (http://www.epeanuts.com/), it seems like a legitimate company.   However, entering the address into google street view, this is the picture that comes up..

While I am not sure if this is the processing facility or facilities, it does seem to match the description painted by the warning letter.

Really makes you think twice about ordering food online, doesn't it?


FDA Warning Letters
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm569815.htm
Coleman Peanut Company 8/2/17
August 2, 2017

FDA Issues Warning Letter To Company Because Proof of Corrective Action to Inspection Items Not Provided

FDA issued a Warning Letter to a Kansas City Company after the company failed to provide evidence or proof of corrective action following an FDA inspection.  So while the company stated in their response letter that corrective action was taken, they failed to provide proof of that corrective action.

While it is hard to know the circumstances involved in this case, it demonstrates what some FDA offices are looking for in terms of response to FDA inspirational observations.

KC Innovations, Inc 3/24/17
March 24, 2017
WARNING LETTER
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549341.htm

FDA Issues Warning Letter to Bakery

FDA issued a warning letter to a California bakery for...a lot of stuff.

- No allergen control

- Poor cleaning - residual raw dough present after cleaning (and we all know this creates a Salmonella / E. coli growth opportunity).

- Leaky roofs - source of Salmonella and moisture

- Poor pest control - presence of insects, poor protection against entry

- Poor personal hygiene practices - people not wearing hair protection
- Improper labeling

With FSMA, bakeries may be getting more attention than in the past.  Because products are generally considered low risk, they have not received the scrutiny of higher risk products.  However, with issues from allergens to Salmonella in flour/dough, they are not risk free.


Nobel Bakery, Inc. 3/16/17

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549608.htm
WARNING LETTER
March 16, 2017
WL# 19-17
Norik Nikogosyan, President/Co-Owner
Nobel Bakery, Inc.
5638 Cahuenga Blvd.
North Hollywood, CA 91601-2103

Warning Letter Issued to Company for Not Verifying That Corrective Measures Worked

FDA issued a Warning Letter to a California company after that company did not adequately respond to a 483 Report issued during inspection.  The inspection was performed after the company's product was involved in a Salmonella outbreak.  During the inspection, Salmonella was found during FDA environmental sampling and this was included as a finding on the FDA 483 that was issued.  From the FDA website: "An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C)".  The company is then expected to send a written response to the 483 report.  "Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously."
When a company does not properly respond and/or take appropriate corrective action, FDA will issue a Warning Letter.  From the FDA website: "When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration's (FDA's) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. (Prior notice is discussed in Chapter 10.) The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law."

As we have seen in a number of other recently issued Warning Letters (Examples 1, 2, 3, 4) companies are failing to properly address the elements of corrective action.  As with this case, measures are taken, but the company fails to verify that those measures have worked.  From this report: "However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak."   The verification that corrective measures worked is especially important after the company has had an outbreak and/or was found to have pathogen contamination issues.

 FDA Warning Letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524491.htm
WARNING LETTER
 October 7, 2016
 

FDA Issues Warning Letter to RTE Facility with LM Issues

FDA issued a warning letter to a Saranac Foods for an inspection completed in February.  We have seen a number of similar types of Warning letters issued.  In this one, inspectors found LM in a facility making RTE product, and  then conditions that would support the spread of that organism (issues with hose usage, condensation, and airflow).  While the company did respond, the response was lacking in terms of a 'complete' corrective action.

 

Listeria

FDA found 3 of 89 samples positive for Listeria monocytogenes. all non-contact but in the ready-to-eat pasta and deli salad production room.

1. Floor near food carts and the 2-compartment sink;
2. The floor alongside of the interior legs of stand mixer;
3. An area of the floor under the 1-compartment sink where a leak is present.

Although the company took corrective action, the FDA stated: FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food. 

  

GMP Issues

Warning Letter Issued to Facility with Recurring Strain of Listeria

Jeni's Splended Ice Cream was issued a warning letter by FDA.  Basically FDA inspected the firm in January, and during that inspection, they found 2 of 75 swabs positive for Listeria.  Both positives were from the floor - non-food contact surfaces.  They also found two GMP issues - 1) "our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored." and 2) observed an employee in the prep room placing  “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers.

Now, it is important to point out that an inspection had been done the previous year and that the 2 GMP violations were previously noted.  More impactful however, is that during that 2015 inspection, FDA had found 20 samples positive for Listeria.  It is also important to note that this audit had been done as a result of a state laboratory finding Listeria in a product sample.

Further, the Listeria was the same strain in all samples "Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015".  (Associated Recall)

So while the firm conducted corrective actions  (conducted a voluntary recall of ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers in 2015, made changes in the production flow including no longer manufacturing finished ice cream, frozen yogurt, or sorbet on-site (instead just manufacturing frozen flavor bases that are shipped to co-manufacturers, and conducted training for employees), the same organism is still in the facility.

"The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism."

A few things to note:

1) This is a reason for facilities to consider using Whole Genome Sequencing (WGS) when they find Listeria in their facility.  Too often the assumption is that it is reentering the facility, but it may be worth determining if there is a resident strain.

2) Although this firm went to great lengths to escape the problem, including changing the products they make, they did not solve the fundamental issue of systematic contamination in the facility.  Although the facility findings were not huge or overly impactful, that issue still existed and resulted in further scrutiny .  WGS had an impact on how FDA evaluated this facility, and making marginal issues bigger than they should have been.  Including finding 2 samples of Listeria in the facility.

3) It is important to fix the issues in an FDA audit report and ensure that they are being followed. Clearly, by having old issues recited gives an auditor or inspector the impression that things have not changed..

4) This points out the long term impact of finding product in the field positive for Listeria.  It the company had more proactive programs first time around, they wouldn't be still trying to work out of the negative image created.

5) The press has been brutal, and although the company claims the product is safe, it is hard to overcome the amount of negative coverage.  Below is an article in the Wall Street Journal countered by an article in Columbus Business First.

Warning Letter Issued to WA State Frozen Food Processor Responsible for Listeria Related Recall

FDA issued a warning letter in response to Oregon Food Company correction of inspection items as part of the Listeria recall of frozen produce.  A few things to note 1) the number of the issues the facility had in the inspection and the fact that they had a pretty big Listeria issue, and 2) their responses were rejected because while the facility addressed items they had to fix, they did not show that the fixes actually worked and that they implemented procedures for ongoing verification.  This is a good lesson in the issues that the plant faced, but also in how to, or how not to, respond to a FDA 483 report.
 
First, the letter points out that FDA found 19 Listeria positive environmental samples with 7 of those being food contact surfaces including a chiller water system (that did not have sanitizer).  These samples were linked via Whole Genome Sequencing to clinical isolates.  While the firm corrected the facility issues, FDA stated that this was not enough. "While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions."  So basically, they want to see results from extensive sampling, including when the plant is operating, that the organism is not present.

 

On GMP issues, the facility was found to be not as clean as it should have been.  While the plant indicated it trained the employees, FDA found the response lacking.  ."your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training."

 
The facility had many condensation issues, which is not good from controlling Listeria.  While the facility responded that they fixed sources of condensation, FDA responded "how you will assess whether this correction and the [fixes] are effective in minimizing the condensation above food and food contact surfaces. Your response does not address how to you will prevent future recurrence of this violation, such as through increased monitoring and assessment."

 

The facility had poorly made food contact surfaces that would provide harborage.  While the facility had repaired the surfaces, FDA responded "you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation. "

 

In addition, there were steam ventilation issues and general facility issues.  Again, fixes were made, but the outcome of those fixes and measures to prevent reoccurrence were not addressed.

 

 

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512776.htm

Oregon Potato Company 7/15/16

 

FDA Warning Letter Issued to Chester, PA Warehouse - Reason...for Being Nasty

We often get questions about the safety of the food supply, and our general response is - overall, our food is safe.  But then, you read something like this and start to think otherwise.   This was an FDA Warning Letter issued to a warehouse / distribution company in Chester, PA.    If you like to look at the outside of the location, you can see the location  on Google maps from 2012 but there are more recent pics on line.

 Observations directly from inspection notes:

• firm did not have running water in either the ladies or men’s restrooms used by employees. Further, the toilets and hand washing sinks were not functioning, and there are no other sinks in your facility.  used buckets, filled with water, to flush the toilets and wash their hands after using the restrooms. You informed our investigator that these buckets are prefilled with water at the hose bib where the water supply line was cut and placed in the restrooms for immediate use and others stored outside the restrooms as reserves to be used later. Further, you informed our investigator that these buckets are used interchangeably for toilet flushing and handwashing and that the buckets are not cleaned or sanitized.
• a wooden desk with dirt and green stains on it, being used as a food preparation table. You informed our investigator that the desk is not cleaned with detergent or sanitizer, and is sometimes wiped down with a paper towel and water from a bucket in the restroom.
• green leafy particles and brown dried debris on knives stored in a wooden desk. You informed our investigator that these knives are used to cut produce and were not cleaned after use, but are cleaned prior to being used again with a paper towel and water from a spray bottle. 
• an orange and white cat was moving freely throughout the warehouse. 
• rodent excreta pellets - multiple occurrences
• mold in coolers - multiple occurrences
• a stack of 5 pallets; a barrel; equipment, and tools that were rusted; and wood and debris were scattered within 3 feet of the west side of the facility where the trailer is located. Further, there were vines draped along the east and west walls, with high grass and weeds that engulfed the perimeter on the south, east and west.
• that the thermometer used in produce cooler #1, where you store vegetables, fruit, and other food articles, was not operational. Further, you informed our investigator that that this thermometer had never been calibrated and was not used for over ten years
• an apparent fetid odor of rot, in unrefrigerated produce cooler #3. You informed our investigator that this is where spoiled products and trash are stored, until taken to the dumpster located outside your facility. For example, a container of spoiled onions, cardboard boxes, and other foreign matter was observed scattered on the floor in the cooler. Further, you informed our investigator that produce cooler #3 has not been cleaned in years.
• an employee smoking a cigarette and grabbing onions with his bare hand from an unmarked box, to fulfill an order for a customer

  

FDA WARNING LETTER

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm509003.htm

16-PHI-07

June 23, 2016

 

Whole Foods Takes Warning Letter on the Chin for February Inspection

FDA issued a warning letter on June 8, 2016 to Whole Foods for an inspection completed back in February.  While Whole Foods responded to the inspection findings in March, the Warning was issued this week (June 8th), because FDA did not find the response acceptable.

"We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections."

The initial inspection found a number of issues, nothing overly serious. but mostly what could be considered sloppy procedures.  This included multiple condensation issues, improper sanitation procedures with instances where too high a sanitizer concentration was used, potential cross contamination issues, inadequate handwashing water temperatures, and improperly marked sanitizing agents.  Environmental sampling of 100 samples was negative for Listeria monocytogenes, but one sample was positive for a non-pathogenic species of Listeria.

Clearly some bad vibes going on between the agency and the plant.  If issues were so bad, why did a follow-up inspection not occur, or why wasn't this letter issued in March?  A lot to take away from this.

• Tighten up procedures now rather than having an agency inspector tell you.  Inspections are rarely perfect, but the number of issues seen here show a lack of attention to detail.
• Ensure corrective actions to inspection reports are completed as soon as possible.Those corrective actions must be detailed / documented to cover each and every element addressed in the inspection and be able to demonstrate that the risk issues have been adequately  addressed .  Overkill in documentation support was needed here rather than glossing over.  

Boston Globe
https://www.bostonglobe.com/business/2016/06/14/whoole-foods-kitchen-everett-hit-with-food-safety-violations/U2oSoRitbt1FeV9s3hFf4K/story.html
FDA inspectors find evidence of Listeria at Whole Foods kitchen
By Megan Woolhouse Globe Staff June 14, 2016

Acidified Food Processor Cited for Improper pH Monitoring - FDA Warning Letter

A Warning Letter was issued by FDA to a acidified food processor for not verifying equilibrium pH.  (Equilibrium pH is measuring the pH after 24 hours to ensure that low acid components within the finished product are below 4.6 in order to prevent Clostridium botulinum growth).

Along with this, there was the lack of production and processing records showing adherence to scheduled processes, lack of a recall procedure, and they were not documenting the calibration of pH meter or the accuracy checks of thermometers and were using expired buffer solutions for pH meter calibration.  
There are many small processors who focus on acidified foods.  With FSMA, more of these processors will fall under FDA jurisdiction / regulations.

For someone looking for co-packing, it is critical to review a companies capabilities beyond what is on the website.  Looking at this company's website, you would think that these folks were operating correctly.  This includes looking at audit reports, and of course, any FDA warning notices.


FDA Warning Letters
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm465325.htm
Backwoods Food Mfg Co Inc 9/15/15
September 15, 2015

2015-DAL-WL-30
Danielle (NMI) Coursey, President, Co-Owner  Michael R. Coursey, Vice-President, Co-Owner
Backwoods Manufacturing, Inc
591 Main Parkway
Tahlequah, OK 74464

Dear. Ms. Coursey,
On March 24-26, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 591 Main Parkway, Tahlequah, OK, where you manufacture a variety of acidified foods. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified food products 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 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. You can find the Act and the Acidified Food regulations through link in FDA’s home page at http://www.fda.gov.