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

Bagged Salad Mix Recalled After Dead Bat Found in Bag

Walmart is recalling their Marketside Spring Mix Salad after the supplier "Fresh Express was notified that extraneous animal matter was allegedly found in a single container of the salad".   That extraneous matter was a dead bat.

While of course, everyone worries about rabies, but this would be an extremely low risk.  Rabies virus is an enveloped virus and does not survive in the environment well if at all. While there have been some rare, laboratory-created instances of it be transmitted through aerosol with depleted oxygen, this is really a non-factor.  The bigger risks are the normal foodborne pathogens that can be carried by bats, including Campylobacter, Listeria, Salmonella, Shigella, and Yersinia as well as some more exotic bacterial types.  Depending on where the bat entered the system would determine the amount of dissemination of these types of organisms.

Now how does bat get into a bag?  If not intentionally placed there by someone, and one had to guess....it would most likely come into the packaging area of the processing plant at night.  The greens are chopped and washed, so unlikely that it came in the loads of produce (unless some component was not chopped).  More likely, this flew into the plant at night when doors were left opened and took refuge in the equipment.  If this were the case, it occurred after sanitation.  When the greens started flowing, the little dude was crushed and loaded into the bag.  All a guess of course, but if true, would probably be in one of the bags from early in the production run..  Prevention....keeping doors shut at night, especially dock doors. X-ray equipment would have likely found this if in place.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm551649.htm
Precautionary Recall of a Limited Quantity of Organic Marketside Spring Mix Salad is Announced by Fresh Express
For Immediate Release
April 8, 2017

Frozen Peas Recalled Due to the Potential for Listeria Contamination

The grocery outlet Aldi is recalling bagged frozen peas after their supplier, Lakeside Foods, notified them of potential Listeria contamination.

While proper cooking would eliminate Listeria, concern would be used in an application where uncooked peas were used, such as a salad.  Freezing during storage and shipment prevents growth, however, if thawed and held at refrigeration temperature or warmer, there can be growth which increases the risk.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm551132.htm
In Association with Lakeside Foods, Inc., ALDI Voluntarily Recalls Season’s Choice Frozen Sweet Peas
For Immediate Release
April 4, 2017

FDA Issues 3 Waivers to Sanitary Transport Rule, Including Shipments by Retail Outlets

With the Sanitary Transport Rule coming, FDA announced three waivers - 1) those permitted to ship milk, 2) those shipping food directly to consumers or as part of the operations of a foodservice / retail outlets, and 3) those approved to ship shellfish.

More specifically, from the FDA on item number two, this gives a waiver to grocery stores and food-service establishments.  It covers food sold directly to the consumer as well as food within the company or affiliate (a supermarket hub operation shipping to one of their stores).

• "Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
  • Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
  • Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as:
    • delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or
    • delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s)."

FDA News Release

FDA Announces Three Waivers to Sanitary Transportation Rule

April 5, 2017

SoyNut Co-packer, Dixie Dew, Slammed in FDA Inspection, Now Suspended

FDA suspended the food facility registration of the co-manufacturing facility of the Soy Nut Butter which was recalled for E. coli contamination.

CDC now reports that there are 29 cases of E. coli infection with 9 people developing HUS.  The majority of cases (83%) affecting people under the age of 18.

FDA inspected the facility (3/3/17 to 3/15/17)  at the same time the initial recall.  FDA issued a 483 report detailing issues in facility.
Here are some of the highlight from the 8 page report.  (For ease, a copy of this document is pasted below, this was converted from the pdf file)

• The firm leaves product in the mix kettle overnight and over the weekend.
• The mixing equipment just shuts off during processing, 1 or 2 times per day, and has had this problem for 15 years.
• They do not calibrate their thermometer used for monitor the nut butter.  
• The chart recorder also does not work.
• During production of product, a clear liquid was observed dripping intermittently form a hole in the ceiling onto the floor and splashing on the equipment.  This was supposedly coming from a leaky pipe.
• Product build-up  on floors and walls, and walking platforms. Standing water on floor.
• Poor employee traffic flow as well as forklift flow, no restriction of movement from dirty areas /waste areas to processing areas.
• Cleaning supplies not properly maintained.
• Wooden pallets sitting in standing water.
• Product piping system not disassembled since 2015, smaller pipes and filling not routinely cleaned.
• Improper employee handwashing.
• Pest control issues.

While this is clearly a co-packer issue, somebody had to approve this company.  Did the IMHealthy folks visit the facility?  Did they recognize the risk, especially considering who would be eating this product - children.  To me, they are just as responsible.

As part of the movement to small, unique brands, more and  more of these small brand companies are turning to co-packers to package their product.  This includes store brands as well.  There are risks however if these co-packers are not properly vetted and managed.  One of the key elements of FSMA, supplier preventive controls, was put in place to prevent this type of travesty.  (This is why I stick to my big brands with lots of food scientists and well developed QA/QC systems protecting that product).

FDA Safety Alerts and Advisories
https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm549734.htm
FDA Suspends Food Facility Registration of Dixie Dew Products, Inc.
No food may leave the facility for sale or distribution
March 30, 2017

Packaging Error Results in Allergen Recall of Nutrition Bar

A nutrition bar company is recalling their crunchy Slim Peanut Butter bars after it was discovered that a product with milk allergen was accidentally mislabeled with the Slim Peanut Butter packaging that does not list milk allergen.

In applying Preventive Controls in the operation that made this product, having a properly implemented Allergen Preventive Control at the point of labeling would help prevent this.  This would include having a step to check the labels for a match to the formulation and then having verification (another person checking, a record review of the labeling record, direct observation of the label check, etc).

This mistake occurred during one shift, but once the depth of the recall expands to store level, this recall can become fairly costly.

FDA Recall Notice

https://www.fda.gov/Safety/Recalls/ucm549680.htm
Lifestyle Evolution Voluntarily Recalls One Shift of NuGo Slim Crunchy Peanut Butter
For Immediate Release
March 30, 2017

Chili Meal Kits Recalled for Potential Salmonella Contamination in Spice Packet

Conagra is recalling its Hunt's brand Chili meal kits after their supplier informed them of potential Salmonella contamination in the spice packets.  No injuries have been reported.

The risk level would not be high in that the chili spice is added and the product is simmered for 10 minutes.  The concern would be if someone adds spice right before eating (keeping the spice out and then adding as they eat it to allow for adjustment of the amount of flavor), or if someone spills the spice on the counter and then that serves as a source of cross-contamination to another food.  For Conagra, not a risk worth taking.

FDA Recall Notice

https://www.fda.gov/Safety/Recalls/ucm550184.htm
Conagra Brands Recalls Hunt’s Chili Kits Due To Potential Presence Of Salmonella In Spice Packet
For Immediate Release
March 2, 2017

Shipping Food Products on Truck or Rail - Get Ready for Sanitary Transport Rule

FDA's Sanitary Transport Rule takes effect in April for the larger firms.  A nice article published in American Trucker outlines how various players (drivers, dispatchers, and planners) will be involved in implementing the rule.   A few things to know - this applies to product shipped from USDA facilities as well as FDA facilities, the shipper or the person arranging shipment has responsibility for that shipment, and smaller shippers have until next year to comply.

American Trucker
http://trucker.com/regulations/new-food-safety-rules-are-you-ready
New food safety rules: Are you ready?
FMSA begins to take effect in April
Mar 30, 2017 Cristina Commendatore