Complaint Filed Against Blue Bell Creameries

The complaint filed May 18 in the class action lawsuit against Blue Bell contains the following direct quotes from the FDA investigation findings re the Blue Bell facilities.

“According to the CDC, a total of ten patients infected with several strains of Listeria monocytogenes were reported from four states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Illness onset dates ranged from January 2010 through January 2015.

“The CDC and the Kansas Department of Health and Environment report that there are five patients who were treated in a single hospital in Kansas and who were infected with one of four rare strains of Listeria monocytogenes.

“FDA was notified that the three strains related to the illnesses reported in Kansas and four other rare strains of Listeria monocytogenes were found in samples of Blue Bell Creameries single serving Chocolate Chip Country Cookie Sandwich and the Great Divide Bar ice cream products collected by the South Carolina Department of Health and Environmental Control during routine product sampling at a South Carolina distribution center, on February 12, 2015. These products are manufactured at Blue Bell Creameries’ Brenham facility.

“The Texas Department of State Health Services subsequently collected product samples from the Blue Bell Creameries Brenham facility. These samples yielded Listeria monocytogenes from the same products tested by South Carolina and a third, single-serving ice cream product, Scoops, which is also made on the same production line.

“On March 13, 2015, Blue Bell Creameries reported that it had removed the affected ice cream products from the market by picking it up directly from the retailers and hospital settings it serves. The company also shut down the production line where the products were made.

“As part of the investigation, the Kansas Department of Health and Environment (KDHE) and the Kansas Department of Agriculture (KDA) collected environmental samples, which are swabs from surfaces likely to come into contact with food, from the hospital kitchen.

“They also collected samples of containers of Blue Bell ice cream still on hand at the hospital. Analysis of the environmental samples did not detect the presence of Listeria monocytogenes. However, one sample taken from a Blue Bell 3-ounce single serving chocolate ice cream cup manufactured in Blue Bell’s Broken Arrow, Okla., plant did show the presence of Listeria monocytogenes. On March 22, 2015, state and federal authorities notified Blue Bell of this finding.

“The CDC reports that three patients reported from Texas had a Listeria monocytogenes strain that is highly related to the strains found in a sample taken from a Blue Bell 3-ounce single serving chocolate ice cream cup made at the company’s facility in Broken Arrow, Okla. Two additional patients, one from Arizona and one from Oklahoma, were confirmed by CDC to be part of the outbreak through whole genome sequencing which showed their strains of Listeria monocytogenes to be highly related to strains found in the Broken Arrow facility.

“On March 23, 2015, Blue Bell Creameries issued a second recall, recalling three flavors of 3 oz. institutional/food service ice cream cups – chocolate (SKU #453), strawberry (SKU #452), and vanilla (SKU #451) – with tab lids because they have the potential to be contaminated with Listeria monocytogenes.

“These products were distributed in Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nevada, New Mexico, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and Wyoming via food service accounts. The company reports that these products are not sold via retail outlets such as convenience stores and supermarkets, and this initial recall did not include Blue Bell ice cream half gallons, pints, quarts, 3 gallons or other 3 oz. cups. The product was sold to schools, nursing homes, and hospitals.

“On April 3, 2015, Blue Bell Creameries announced that the firm had voluntarily suspended operations at its Broken Arrow, Okla., plant.

“On April 7, 2015, FDA notified Blue Bell Creameries of Brenham, Texas, that Listeria monocytogenes was present in samples of Blue Bell Banana Pudding Ice Cream pints. FDA collected the samples as part of a joint inspection with the Oklahoma Department of Agriculture, Food, and Forestry (ODAFF) of the Broken Arrow plant which began on March 23, 2015. During the inspection, the ODAFF collected a sample showing the presence of Listeria monocytogenes from a 3 oz. Blue Bell chocolate ice cream cup with a tab lid, which was part of an earlier recall by Blue Bell Creameries.

“On April 7, 2015, Blue Bell Creameries expanded the recall of ice cream manufactured in its Broken Arrow, Okla., plant to include additional products that have the potential to be contaminated with Listeria monocytogenes. The company has reported that the recalled products were manufactured on the same production line that produced the ice cream that showed the presence of Listeria monocytogenes and that the products were manufactured between February 12, 2015, and March 27, 2015.

“The products being recalled are distributed to retail outlets, including food service accounts, convenience stores, and supermarkets, in Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nevada, New Mexico, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and Wyoming.

“Additionally, Blue Bell Creameries has reported that on April 4, 2015, the firm began working with retail outlets to remove all products produced in Broken Arrow, Okla., from their service area. These products are identified with a code date ending in O, P, Q, R, S, or T located at the bottom of the carton.

“On April 20, 2015, Blue Bell Creameries of Brenham, Texas, voluntarily expanded its recall to include all of its products currently on the market because they have the potential to be contaminated with Listeria monocytogenes. Samples taken by the firm show the presence of Listeria monocytogenes in Chocolate Chip Cookie Dough Ice Cream half gallons produced on March 17 and March 27, 2015. Although FDA environmental sampling has not shown the presence of Listeria monocytogenes on food contact surfaces in any Blue Bell facilities, sampling identified the presence of Listeria monocytogenes in other areas of the Blue Bell production facilities in Broken Arrow, Okla., and Sylacauga, Ala.”

The FDA inspected the Blue Bell Creameries Broken Arrow, Oklahoma, manufacturing plant between 03/23/15 and 04/23/2015, at which time the inspectors collected information regarding samples taken in 2013, 2014 and 2015; in addition, the FDA collected samples on 03/24/15 and 03/25/15.

The FDA’s investigation confirmed that Listeria was present throughout Defendants’ Broken Arrow, Oklahoma, plant on the dates of inspection and in the years preceding the inspection.

On 01/13/14, samples taken from Defendants’ manufacturing plant in Broken Arrow, Oklahoma, were sent to its third-party laboratory, who received the samples on 01/14/14. The laboratory reported the samples as positive for Listeria spp. on 01/16/14. The area that tested positive was re-sampled on 01/20/14. The laboratory again reported the samples as presumptive positive for Listeria spp. on
01/23/14. The area sampled was documented as being cleaned and sanitized between 01/13/14 and 01/17/14; however, it failed to be cleaned and sanitized adequately and showed evidence of Listeria spp. on two consecutive samples.

On 04/15/14, samples taken from Defendants’ manufacturing plant in Broken Arrow, Oklahoma, were sent to its third-party laboratory, who received the samples on 04/16/14. The laboratory reported the samples as positive for Listeria spp. on 04/19/14. The area that tested positive was re-sampled on 04/22/14. The laboratory again reported the samples as presumptive positive for Listeria spp. on
04/25/14. The area sampled was documented as being cleaned and sanitized between 04/15/14 and 04/21/14; however, it failed to be cleaned and sanitized adequately and showed evidence of Listeria spp. on two consecutive samples.

The Oklahoma Department of Agriculture, Food and Forestry has a regulatory requirement of 20 Colony Forming Units (CFUs)/mL or less in finished products of frozen dairy desserts.

Total coliform greater than 20 CFUs/mL was identified in Defendants’ finished products, in-process product batches and raw ingredients in six (6) samples during April of 2014, eight (8) samples during January of 2015, twenty-three (23) samples during February of 2015, and ten (10) samples during March of 2015.

Total coliform identified in April of 2014 ranged from 33 CFUs/mL to 105 CFUs/mL and included the following:

a. Finished product of Defendants’ Pineapple Sherbet tested on 04/15/14 contained 33 CFUs/mL;
b. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 04/22/14 contained 34 CFUs/mL;
c. In-process product of Defendants’ BBIC Vanilla in a “Flavor Tank” tested on 04/25/14 contained 105 CFUs/mL.

Total coliform identified in January of 2015 ranged from 48 CFUs/mL to 124 CFUs/mL and included the following:

a. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 01/12/15 contained 48 CFUs/mL;
b. Finished product of Defendants’ Dutch Chocolate Ice Cream tested on 01/21/15 contained 124 CFUs/mL;

Total coliform identified in February of 2015 ranged from 25 CFUs/mL to 840 CFUs/mL and included the following:

a. Finished product of Defendants’ Dutch Chocolate Ice Cream tested on
02/09/15 contained 275 CFUs/mL;
b. In-process product of Defendants’ Homemade Vanilla in a “Flavor Tank”
tested on 02/24/15 contained 228 CFUs/mL;
c. In-process product of Defendants’ Homemade Vanilla in a “Flavor Tank”
tested on 02/26/15 contained 796 CFUs/mL;
d. In-process product of Defendants’ Homemade Vanilla in a “Flavor Tank”
tested on 02/26/15 contained 392 CFUs/mL;
e. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 02/24/2015 contained 151 CFUs/mL;
f. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 02/24/2015 contained 174 CFUs/mL;
g. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 02/26/2015 contained 840 CFUs/mL in the morning and 223 CFUs/mL in the afternoon; Defendants’ product was resampled on 2/27/15 and found to contain 25 CFUs/mL, 46 CFUs/mL and “Too Many to Count” CFUs/mL;
h. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 02/26/2015 contained 377 CFUs/mL; Defendants’ product was resampled on 02/27/15 and found to contain 88 CFUs/mL and 142 CFUs/mL.

Total coliform identified in March of 2015 ranged from 24 CFUs/mL to 121 CFUs/mL and included the following:

a. Finished product of Defendants’ Sundae Ice Cream tested on 03/06/2015 contained 67 CFUs/mL;
b. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 03/09/2015 contained 121 CFUs/mL;
c. In-process product of Defendants’ Homemade Vanilla in a “Flavor Tank” tested on 03/16/2015 contained 107 CFUs/mL;
d. Finished product of Defendants’ Homemade Vanilla Ice Cream tested on 03/16/2015 contained 24 CFUs/mL.

Defendants’ Cleaning-in-Place (CIP) and Cleaning-Out-of-Place (COP) procedures were inspected by the FDA, during which it was discovered that the water temperature for washing and rinsing the exterior surfaces and COP was not continuously monitored, verified or documented. Additionally, the water temperature for Defendants’ CIP system used to clean and sanitize the food contact surfaces of the mix tanks, flavor tanks, freezers, fillers, and connecting pipes was not continuously monitored, verified or documented.

Defendants’ startup and final water temperatures used during CIP and COP procedures were checked by the FDA and found to be inadequate according to the manufacturer of the sanitizer used by Defendants in the CIP and COP process.

Defendants allowed condensate to drip on the tops of the enclosed “Flavor Tanks” wherein food product is contained. Although the “Flavor Tanks” are enclosed, the FDA inspectors observed that the condensate is not prevented from entering the “Flavor Tanks” through loose fitting gaskets.

FDA inspectors observed Defendants’ employees remove a tank lid from one of the “Flavor Tanks” and place the lid interior side down on top of another “Flavor Tank” that was covered with condensate, and then replace the tank lid, exposing the interior of the tank and the food product therein to external condensate.

FDA inspectors observed condensate dripping directly into quart containers while the product was being filled and packaged, and on to cardboard cases of product.

On several occasions on 03/26/15, FDA inspectors observed Defendants’ employees failing to change gloves and wash hands thoroughly before making contact with the food product.

The FDA previously cited Defendants for failing to properly wash and sanitize hands in 2012.

Defendants did not have any procedure for cleaning or sanitizing the footwear of Defendants’ employees prior to entering sanitary food production areas. Employees were observed by FDA investigators as traveling between sanitary and nonsanitary areas such as dry goods storage, maintenance shops, offices, break room, outside smoking areas, etc. without cleaning and sanitizing prior to re-entry into the sanitary food production area.

Defendants were observed using wooden pallets throughout the Broken Arrow plant for storing raw ingredients, finished product and packaging materials. The pallets were broken, discolored and soiled. The pallets were also observed by FDA inspectors to be saturated from being used in the wet processing areas and as having black mold-like residues and red stains.

Defendants were observed storing unpasteurized milk products as raw ingredients in temperatures above 45°F.

Defendants’ stainless steel mixer at the Broken Arrow plant had rough and non-continuous welds along the back and side splash guards. The nature of the welds makes the mixer difficult to clean and the gaps can harbor microorganisms; however, the mixer was being used to mix granulated sugar and thawed sliced strawberries for use in Defendants’ product.

Defendants failed to disassemble a freezer to thoroughly clean it, despite having reported the freezer to be “clean” following the CIP procedure. The freezer’s gasket and faceplate were observed by FDA investigators as having a black, mold-like residue where the gasket forms a seal between the faceplate of the freezer and the freezer body.

On 02/13/15, the Texas Department of State Health Services notified Defendants that products originating in their Brenham, Texas, plant tested positive for Listeria monocytogenes. Defendants resumed operations and manufactured on 03/02/15- 03/06/15 and on 03/09/15. On 03/09/15, despite reporting that routine cleaning and sanitizing had occurred after each manufacturing day, Defendants found Listeria monocytogene from swabs taken on food contact surfaces.

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