FDA Issues Warning Letter to Michigan Juice Operation for Juice HACCP Violations

FDA issued a Warning Letter to a Michigan juice processor who did not have a HACCP plan in place.  It seems the operation was trying to skate between the Juice HACCP regulation and the Preventive Controls regulation.  The issue was that the company used a central kitchen to produce juice for sale at that central operation but also sell it form smaller juice operations under the control of the company.

"A “retail establishment” is defined by the juice HACCP regulation as “an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers” (21 CFR 120.3(l)). In short, a retail establishment (1) provides juice directly to consumers and (2) does not sell juice to other business entities. Your Berkley facility sells juice to other business entities. Therefore, it is not considered a retail establishment, and the juice HACCP regulation applies to all of the juice produced at that location. Also, note that as reflected in the guidance you reference in your May 19, 2020 response (i.e., Answer 19 of Guidance for Industry: Questions and Answers on juice HACCP Regulation), juice is only considered to be provided directly to consumers if it is provided to consumers at the same location where it is produced. Accordingly, if you no longer provide juice to consumers at your Berkley facility, then it is not considered a retail establishment for this additional reason."


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/panther-james-llc-610082-03052021
Panther James LLC
MARCS-CMS 610082 — MARCH 05, 2021
Product:  Food & Beverages

FDA Issues Warning Letter to Potato Chip Manufacturer for Allergen Mislabeling

FDA issued a Warning Letter to Frito Lay for two allergen related issues that resulted in recalls.    One occurred when at the Bakersfield, CA facility when  incorrect seasoning containing undeclared milk was applied to Lay’s Barbecue Flavored Potato Chips  and the other was a mislabeling issue at the Vancouver, WA facility when  bags of Ruffles Cheddar & Sour Cream Potato Chip potato chips were labeled “Ruffles Original Potato Chips”.  Basically, the two facilities had procedures but did not follow them.

Mislabeling at WA facility

According tot the report , the facility did not adequately implement food allergen controls at the packaging step allowing incorrect labeling where Ruffles Cheddar & Sour Cream Potato Chips were bagged as Ruffles Original bags, thus an undeclared major food allergen, milk. 

In this case, the facility did not implement their roll change procedure - they were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, the bagmaker operator incorrectly used the Ruffles Original film. 

The allergen control procedure, “Film Splice Tracking,” is in place to indicate that at roll change the person will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and then a second person will verify the labeling film code. 

• These splice operations were not documented on the form. 
• Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form. 
• Further, the firm discontinued attaching the labeling film splice to the form in June of 2020.

Additionally, there was a procedure to verify the correct product is in the correct package and bag coding/case coding information is accurate. "The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.”   Further wo employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted."

Allergen Cross Contact at the Bakersfield CA facility

The firm did not adequately implement the "Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. "These procedures indicate that [the firm] will verify that all visible evidence of prior seasoning is removed [after] cleaning. On September 23, 2020, (b)(4) cleaning of packaging line (b)(4) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (b)(4) cleaning, was observed by our investigator. In particular, three orange residues approximately one millimeter in size were observed on the (b)(4) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (b)(4). These residues were observed after you conducted a (b)(4) clean-out and documented on your “(b)(4)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by your PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk."

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/frito-lay-inc-611243-11242020
WARNING LETTER
Frito-Lay, Inc.
MARCS-CMS 611243 — November 24, 2020 

FDA Warning Letter - CA Ice Cream Facility Has Inadequate Listeria Control

FDA issued a Warning Letter to a California ice cream company primarily due to inadequate Listeria control.  The FDA "inspection was initiated in response to your firm’s voluntary recall of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream (Best Before 10/08/2021), due to findings of Listeria monocytogenes (L. monocytogenes) in the product."

Listeria was found in multiple locations including the bristles of a broom.  The facility also continuously found Listeria during sampling but the corrective actions were not effective.  From the FDA report -  "it appears that your corrective actions were not adequate to address your findings, as evidenced by the recurring findings of Listeria within your environment, including some within the same locations."

This is interesting  - "You identified improper employee handling of boxes of chocolate chips that were transported into the RTE Production Room via dollies and placed on the floor before being added to the (b)(4) machine as the root cause of L. monocytogenes finding in the recalled lot of Peekaboo brand ice cream. Your corrective actions included prohibiting the use of floor dollies on the production floor and replacing them with a (b)(4) cart for transporting and holding inclusions in the RTE Production Room. However, on May 21, 2020, this cart was observed sitting outside the building with one of its wheels in standing ground water. You swabbed this ground surface on May 21, 2020, and the result was positive for Listeria spp. On May 27, 2020, this cart was observed inside the RTE Production Room and you did not have a process for cleaning and sanitizing it when bringing it from the outside into the RTE Production Room."

There were a number of GMP issues including dripping hoses, the bringing in of items from an outside warehouse into an RTE environment, inadequate hand washing station, and improper sanitation of utensils and equipment.

FDA Issues First Injunction Under Produce Safety Rule Shutting Down an Illinois Food Processor

The FDA issued the first injunction against a firm or grower for violating the Produce Safety Rule enacted under FSMA.  The Illinois processor  of sprouts and soy products has stopped production until it undertakes corrective action and comes in compliance with the regulations.  This comes after FDA had conducted multiple inspections where they documented insanitary conditions showing that sprouts and soy products had been produced in insanitary conditions.

The company had been issued a Warning Letter in July in which identified violations where significant evidence of rodent activity and insanitary conditions and practices throughout the farm mixed-type facility. Based on these findings, FDA determined that the mung bean sprouts, tofu products, and soybean noodle products were adulterated.  They noted employees shoveling product back up off the floor, product getting hung up in equipment, poor water handling systems, an inadequate Listeria control program,  extensive rodent infestation, inadequate handwashing facilities,  inadequate allergen labeling, etc.


FDA News Release
https://www.fda.gov/news-events/press-announcements/fda-issues-first-injunction-under-produce-safety-rule-illinois-based-food-manufacturer-repeated-food
FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations

For Immediate Release:
September 15, 2020

The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letters Issued to Importers for Non-compliance to FSVP

FDA issued Warning Letters to four importers for not have Foreign Supplier Verification Programs in place for the food items these companies were importing. FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.


Martinez Mexican Produce, LLC, at 1704 N. International Blvd., Hidalgo, TX 78557.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/martinez-mexican-produce-llc-607645-06162020

Fides New York Inc. located at 4725 208th Street, Bayside, NY 11361-3214
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fides-ny-inc-608989-07292020

Gourmet and More, Inc. located at 2976 Alvarado St., Ste D, San Leandro, CA 94577.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gourmet-more-608887-07312020

Grupo RM USA, Inc., located at 7991 NW 82nd Ave. Miami, FL 33166.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grupo-rm-usa-inc-609291-08062020

FDA Issues Warning Letter to South Carolina RTE Sandwich Company for Failure to Control Listeria

FDA Issued a Warning Letter to Grand Strand Sandwich Shop after investigators found Listeria in the processing environment.  This strain was the same strain that was found in previous inspections.

"Environmental swabs collected during each of the past three FDA inspections revealed L. monocytogenes in your facility as follows:

- 2020: four (4) swabs collected from locations adjacent to food contact surfaces.

- 2018: seventeen (17) swabs primarily collected from food contact surfaces and locations adjacent to food contact surfaces.

- 2017: five (5) swabs within your facility primarily collected from locations adjacent to food contact surfaces.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. The current WGS analysis determined that the isolates derived from the samples collected at your facility during our 2020, 2018, and 2017 inspections represent a single strain of L. monocytogenes0".

FDA indicated that the company's corrective action when finding Listeria was not adequate in that FDA found Listeria in the same locations that the company had found Listeria.

"Your firm implemented corrective actions, which included cleaning and sanitizing, followed by conducting environmental swabbing on that location to determine these were effective. On February 24, 2020, FDA’s environmental swabbing isolated L. monocytogenes from a (b)(4) in your (b)(4), which appears to be the same location of your January 6, 2020 finding."

The company also failed to recognize a hazard for an ingredient they purchased...more specifically L. monocytogens in the purchased RTE ingredients used in making sandwiches.

There were additional issues associated with verification and allergen control.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grand-strand-sandwich-company-inc-607559-08042020
Grand Strand Sandwich Company, Inc.
MARCS-CMS 607559 — August 04, 2020

FDA Issues Warning Letter to NJ Cheese Processor - No Preventive Control Plan and No Listeria Control Program

FDA issued a Warning Letter to El Abuelito Cheese, Inc. of Patterson NJ for not having a Preventive Control Plan in place for each type of food processed.  They also did not have a Listeria control program in place.  While investigators found Listeria in the processing facility, the strains they found were not pathogenic.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-abuelito-cheese-inc-605472-06042020
WARNING LETTER
El Abuelito Cheese, Inc.
MARCS-CMS 605472 — June 04, 2020

FDA Issues Warning Letter to AZ Candy Company

An Arizona candy company was issued a Warning Letter by FDA.
The main issues were:
1) In the hazard analysis, they did not evaluate all of the ingredients used in the product.  The hazard analysis must evaluate every ingredient in the process.
2) There was an issue with the environmental monitoring.  I have a little issue here with the FDA's statements.  Environmental monitoring is specific for the facility.  There should not be a need for testing for Listeria in a candy facility.  Not to say environmental monitoring is not needed, however, I would like to see some additional support for the comments FDA is stating in this item.
3) The firm was buying raw nuts and roasting them, but the firm claimed that Salmonella was not a hazard because there was Supplier Control.  But clearly, the firm would have a Process Preventive Control in terms of Roasting.
4) The firm did not have a good pest control program.

From the report, Item 1.
Your hazard analysis for your RTE peppermint snow mints, chocolate pretzel clusters, and cinnamon honey peanut butter did not include an evaluation of all ingredients used to manufacture these products.
Specifically,
a. The hazard analysis for "[Chocolate] Molding," which applies to its use in peppermint snow mints, did not identify or evaluate potential hazards for the ingredient crushed peppermint/candy cane, such as recontamination with environmental pathogens and unapproved colors/additives.
b. The hazard analysis for "[Chocolate] Molding," which applies to its use in chocolate pretzel clusters, did not identify or evaluate potential hazards with the ingredient pretzels, such as recontamination with environmental pathogens.
c. The hazard analysis for (b)(4), which applies to the performance of this activity to make cinnamon honey peanut butter, did not identify or evaluate potential hazards for the ingredient ground cinnamon, such as Salmonella spp. and heavy metals, and for the ingredient honey, hazards such as drug residues and pesticides.

FDA Issues Warning Letter to Manufacturer of RTE Ingredient

FDA issued a Warning Letter to an Ohio firm that manufacturers RTE ingredients.  The problem was that the firm had a Listeria issue (discovered by their customer who tested the product and probably reported via the Reportable Food Registry).  Upon inspection by the FDA, the firm did not have good cleaning procedures and was not responding to Listeria positive samples.  The firm did not not implement effective corrective action procedures to include that root cause analysis, specifically - "did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."  The firm also had some poor practices including the use of high pressure hoses as well as improper cleaning of transfer pipes.

From the Letter

• "Specifically, your food safety plan identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard, but you did not fully implement your “Sanitation Standard Operating procedure (SSOP), We also gathered documentation that one of your customers tested and found your aji amarillo paste to be positive for L. monocytogenes." 
• "In addition, a review of records of your weekly environmental monitoring program for Listeria spp. shows that (b)(4).  (b)(4) collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, your finished aji amarillo paste product was found to be positive for L. monocytogenes (b)(4)."
• "Whole genome sequencing analysis showed the L. monocytogenes isolates from the environmental swabs collected by FDA were the same strain as that in the finished product aji amarillo paste tested by your customer. Your environmental testing results and these findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent the hazard of L. monocytogenes in your facility"
•  "You did not implement your written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through your environmental monitoring, as required by 21 CFR 117.150(a)(1)(ii). Specifically, in your food safety plan, you identified (b)(4). (Environmental monitoring is a verification activity for preventive controls as reflected in 21 CFR 117.165(a)(3).) Your environmental monitoring program lists the following corrective actions after a presumptive positive for Listeria spp.: (b)(4). Your weekly environmental monitoring program for Listeria spp. (b)(4). Each time, your corrective actions were limited to (b)(4). You did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."
• "You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). On March 28, 2019, our investigator observed an employee using a high-pressure hose to spray the mezzanine floor with water while performing sanitation operations. Water overspray created a mist surrounding the open medium ribbon blender used to manufacture aji amarillo paste. On April 2, 2019, our investigator observed water overspray around the blue (b)(4) pallets on which employees were cleaning product transfer hoses, (b)(4) blades, a (b)(4), (b)(4) hopper, and (b)(4) fixtures used in the manufacture of the aji amarillo paste. Our investigator also observed an employee cleaning a product transfer pipe without cleaning the full interior of the pipe."

FDA Warning letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yost-foods-inc-581473-09102019
Yost Foods, Inc 
MARCS-CMS 581473 — September 10, 2019

FDA Warning Letter to RTE Cheese Processor

FDA issued a Warning Letter to a cheese facility in Miami.  Issues include no Preventive Control Plan and really poor GMPs (dripping condensate, leaking pipes, and inadequate sanitation).  And they are producing RTE cheese product of some sort.

The thing that gets you is the company name....US Dairy Unlimited.   You are thinking with a name like that, that is a serious operation.  Could have called it Ury's Cheese, but who would buy that.  But US Dairy Unlimited....there are no limits to what they can do, or so one would think.

But looking at the facility (based on address from notice on Google Map Street view), it looks like nothing like Dairy Unlimited.  Not to say they can't make good products, but if this is your supplier, you may want to investigate a little closer.  For example, your purchasing person informs you that they have contracted a new co-packer....US Dairy Unlimited.  What supplier approval process granted this?

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-dairy-unlimited-llc-590413-11192019
WARNING LETTER
U.S. Dairy Unlimited, LLC
MARCS-CMS 590413 — November 19, 2019

FDA Warning Letter - Ice Cream Facility in MA

FDA sent a Warning Letter to an ice cream facility in MA.  Lots of good things to learn from this inspection.

One of the major issues was that the facility had a Listeria control issue.

One of the first citings was that the establishment said that it did not require a sanitation control for Listeria in the post process environment where the product is exposed.  The facility said that because it had SSOPs, GMPs, and environmental monitoring, these were reasons why it does not have to considered a preventive control.  Doesn't work that way.

our “FSMA/FOOD SAFETY PLAN” issued on June 10, 2019, lists pre-requisite programs (PP) and Sanitation Standard Operating Procedures (SSOP), “PP1- Environmental Monitoring,” “PP3-current Good Manufacturing Practices,” “SSOP1- Cleanliness of Food Contact Surfaces,” and “PP7-SSOPs,” at processing steps where food is exposed to the environment, as reasons that a hazard (e.g., L. monocytogenes) does not require a preventive control. However, for RTE foods exposed to the environment, SSOPs are sanitation controls that are verified by environmental monitoring. These measures should not be considered when determining whether sanitation preventive controls are needed. Environmental monitoring (e.g., Dean Foods’s corporate environmental monitoring program “PP1- Environmental Monitoring Preventive Control” and/or your facility specific “Pathogen Environmental Monitoring Program”) is needed to verify that environmental pathogens are being controlled by the sanitation control measures. 

 Listeria was found in the environment during the FDA inspection, the same strain in some cases that was found during an inspection in 2017.  The firm's own swabbing had found a high level of Listeria.

"from January 2019 through July 2019, 13.4% of all swabs taken were positive for Listeria spp.; from January 2018 through December 2018, 20.9% of all swabs taken were positive for Listeria spp.; and from January 2017 through July 2017, 16.4% of all swabs taken were positive for Listeria spp."

GMP issues (continues)

FDA Warning Letter - RTE Salad Company

FDA issued a warning letter ready-to-eat RTE prepared foods manufacturing facility that produced RTE salads.  There are issues with the Preventive Control Plan as well as GMP issues.  One of the interesting items regarding their plan was that they were not following it.  Item number 3 below points out how many people write up a plan, and in that plan, they overstate what they do.

1) Listeria was found in the facility, the same strains of Listeria that were found in previous inspections - "FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections".  "Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of L. monocytogenes. Specifically, the same strain of L. monocytogenes was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017."

Because of this it can be stated that Sanitation Preventive Controls were not adequate -
The facility "identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary"

2) FDA identified SSOPs that were not being followed - The company "did not implement the written sanitation control procedures identified in your SSOP entitled "

3) The company did not follow their own Supplier Preventive Controls - the Plan "states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list.  Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad.  Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier"

4) GMP issue- Food stored directly on ground - "bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway (b)(4) room.  This area was observed to be a high employee and equipment traffic area.  These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area, (b)(4) was being washed and sanitized using (b)(4) that occasionally sprayed beyond the (b)(4) into the area where the vegetables were stored.

5) GMP issue - leaking valves through the facility - "during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement"


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hans-kissle-company-llc-584080-09242019
WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 — September 24, 2019

FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or 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 U.S.C. § 331(uu))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

FDA Issues Warning Letter to Ice Cream Facility for Inadequate Listeria Control

FDA issued a warning letter to an Ohio ice cream facility after finding Listeria monocytognes on consecutive inpections still in the facility.  From FDA's perspective, the facility had not done sufficient corrective action to reduce this environmental bacterial pathogen.

FDA stated "Nine environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in nine swabs within your facility and environmental swabs collected during our 2017 inspection revealed L. monocytogenes in three swabs within your facility."  Further,  "FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes),...... including the same strain found during FDA’s 2018 inspection."

The facility conducted had their own testing and from their results,  "Listeria spp. [was found] in your environment seven times on surfaces adjacent to Zone 1 locations and other non-food contact surface locations within your processing environment including areas within your RTE room. Review of your records finds that your written corrective action procedures were followed each time a positive swab was found in your facility; however, these repeated findings of Listeria in your environment are further evidence that additional measures may be needed in your facility to address Listeria."

Along with this, the inspection noted items of risk including improper use of high pressure hoses which can cross contaminate back onto food surfaces.  "[FDA] investigators observed an employee using a high-pressure hose to spray the floor with water while performing sanitation operations. They observed overspray from the floor onto equipment reported as having been cleaned and from the floor onto unopened buckets of ingredients that were going to be used to produce ice cream the next day."

The other issue was poor drainage from the processing floor - "the design of the production floor does not allow for the proper drainage of water. Water used in the cleaning of equipment pools in various locations throughout the production area of your facility, which can provide harborage areas for pathogenic bacteria such as Listeria."

Once Listeria becomes established in a facility, it can become difficult to eliminate.  The level of positive Listeria swabs are clear indication that corrective actions were not sufficient. The Blue Bell Listeria contamination issue where corrective action to Listeria positive findings were also inadequate. .


FDA WARNING LETTER
Velvet Ice Cream Company 
MARCS-CMS 575444 — 06/05/2019
  Delivery Method:VIA UPSProduct:Food & Beverages
Dairy
Current Good Manufacturing Practices (CGMP) 

FDA Warning Letter - MN Warehouse with Egregious GMP Violations

FDA issued a Warning Letter to the owner of a warehouse facility in Minnesota due to egregious GMP violations.  Hard to imagine food being stored in these conditions.

1. Did not take effective measures to exclude pests from your packing and holding areas to protect against contamination of food on the premises by pests - dead rodents, gnaw marks and holes in product, rodent droppings and live birds.
2. Did not maintain your building, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated - leaky roof with damp/wet product below, product spillage in multiple locations
3. Did not store food under conditions that protect against biological, chemical, and physical contamination - improper chemical storage with the potential for contamination of food, refrigated food stored at ambient temperatures.
4. Failed to properly store equipment, remove litter and waste, and cut weeds and grass that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant,

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624404.htm
Gold Star Distribution., Inc. 10/19/18

FDA Issues Warning Letter to NY Processor for Nastiness

The U.S. FDA issued a Warning letter to a NY firm that manufacturers Ready-to-Eat (RTE) single serve condiment manufacturing and has a warehouse facility.  Based on FDA’s findings during the inspection, the FDA determined that the food products were adulterated within the meaning of regulation in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.

The issues were too numerous to detail, so in summary:

• Were packing product that had a pH above 4.6 without proper controls for this low acid product.
• Lots of dead rodents and lots of rodent poop (REP -rodent excreta pellets)
• Roaches
• Unclean surfaces and equipment
• Condensation issues
• Improper processing and cleaning procedures

Elwood International has a website. From the website about the company:

30 years ago, Elwood began making dietetic portion controlled products exclusively for hospital service. Today, Elwood is a recognized leader in the dietetic food industry; with a complete line of Salad Dressings, Jellies and Condiments specifically formulated for diabetics and others who must follow modified and restricted diet meal plans.
Elwood manufactures a complete line of great tasting sucrose-free foods that diabetics can trust, such as:
Salad Dressings, Jellies, Sauces, Condiments and Pancake Syrup. Some of our exciting flavors are Russian, Oil & Vinegar, Thousand Island and Blue Cheese Salad Dressings, Cranberry, Tartar, Barbecue and Seafood Cocktail Sauces, Strawberry, Grape, Apricot, Raspberry and Apple Jelly, Pancake Syrup and Condiments like Mayonnaise and Mustard.  

So great, this product is going to people likely to be considered high risk.

FDA Warning Letter

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623049.htm
Elwood International, Inc. 9/27/18

Cereal Facility Issued Warning Letter for Inadequate Salmonella Control

FDA issued Kerry Inc a warning letter for their Illinois cereal facility after FDA testing found Salmonella and an FDA audit found that the facility had found numerous Salmonella positive environmental samples.  The FDA ruled that the product was "was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health".  This is a very interesting case study for product that was most likely used as an ingredient in further processing.

One of major issues was the Salmonella positive samples. From the report:  " Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

 A summary of the points made in the warning letter:

1. The hazard analysis of RTE cereal process did not list environmental pathogens when the finished product was exposed to the environment prior to packaging. This was especially concerning since the facility did find Salmonella in the environment
2. Environmental controls to prevent Salmonella were not implemented sufficiently to control Salmonella. FDA found Salmonella in the processing environment as well as the facility found Salmonella.
3. Corrective actions were not properly implemented to get rid of Salmonella. There were no steps taken to remove the root cause of the Salmonella from the enviromet. Basically, a root cause analysis was not completed even though Salmonella was constantly being found.
4. Sanitation controls were not verified. The company did not follow its own SOP for environmental monitoring

There was no further information regarding the facility, but as an ingredient manufacturer, it is likely that this cereal product is made for use as an ingredient  in foods that will be further processed.   Perhaps this is why a less-than-sufficient effort.  Regardless, 1) FDA viewed this as an RTE product and that may have been difficult to convince otherwise - including providing notice to customers 2) the company should have included it in the hazard analysis, and 3) a better effort should have been made in controlling it.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615073.htm
Kerry Inc 7/26/18

Warning Letter Issued to Bean Manufacturer for Inadequately Handling Can Seam Issue

Bush Beans was issued a warning letter related to how they handled a can seam issue this past summer.  Although a recall was conducted, FDA cited the plant for not notifying FDA of the issue, minimizing the issue even though a container failure issue could be danger to the public, and failing to take appropriate action regarding in-process rejects.  The issue was that the firm did not take appropriate action to a supplier related can seam issue. Can seam issues for low acid canned foods can result in serious issues such as the potential for Clostridium botulinum.

The warning letter specified two major items:
1.  Failed to promptly report to FDA any instance of spoilage or potential public health significance where any such lot of food had in whole or in part entered distribution, by distributing bean products after a side seam defect was identified by plant personnel and confirmed by the can manufacturer.  The issue was identified as a weld adhesion failure on the side seams.  The company only considered a market withdrawal for cans manufactured on one day identified as having the most can seam defects, but other dates were involved. "The explanation provided to the FDA Investigators was that your Quality Assurance Department identified this as a food quality issue and not a food safety issue."  Additionally, the firm did not conduct any microbiological tests on the questionable lots at the time of the inspection, and, was not able to give assurance that those products would pose no significant health risks to consumers due to potential post-process contamination based on the observed side seam defect.  The firm did not routinely do microbiological analysis of the cooling water, which while not expressly required, it is important to show control.

2.  Failed to perform and record defects of containers, and perform a corrective action when cans were identified as losing their hermetic seal.  Basically, the firm had an inline dud detector to determine which cans had lost vacuum, but the record keeping was poor and there was no follow-up to cans that were rejected.

The Low Acid Canned Food regulations (LACF) are in place for all those who package low acid canned foods where Clostridium botulinum can be an issue. 


https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578558.htm
September 29, 2017
Warning letter 535494

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

FDA Warning Letter - King of Pops - Nasty Food Operations Exposed

FDA issued a warning letter to a GA firm after that firm inadequately responded to the findings of an FDA inspection.

The findings - pretty nasty especially considering this company is producing ready-to-eat foods, and if we had to guess because they are ice pops, will be eaten by children.

• Rodent droppings throughout the facility.
• Food residues on equipment
• Untreated and unsanitary floors
• Improper glove usage - not changing gloves after touching unsanitary surfaces.
• Inadequate floor drainage leading to standing water
• Table top surfaces not of sanitary construction - not cleanable.
• Not removing debris from production area in a timely manner.
• Large gaps in facility capable of allowing pests in.
• Exposed glass light bulbs in production areas.

Looking at the facility, it appears to be just a bad looking retail location.

But looking at the website, you can see it is a much larger operation.  Started by some young corporate-dropout types, it looks as though they never took the time to learn about safe food processing, or the need to implement food safety systems.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm572052.htm
August  3, 2017