As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Bainbridge Beverage West, LLC
West Sacramento, CA
A food firm in California is on notice from the United States Food and Drug Administration (FDA) after not identifying Hepatitis A and Cryptosporidium parvum as hazards in their written hazard analysis, among other violations.
In a Nov. 28, 2022, warning letter, the FDA described a June 9, 10, 22, 24 and 29, 2022, inspection of Bainbridge Beverage West, LLC’s juice manufacturing facility in West Sacramento, CA.
The FDA’s inspection revealed that the firm had serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation, and resulted in the issuance of an FDA Form 483.
Some of the significant violations are as follows:
1. The firm did not validate that their HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way.
The firm was informed on June 1, 2022, that organic fresh strawberries (from “(redacted)”) that they received were potentially contaminated with hepatitis A. They used these strawberries in the juice products (redacted) and (redacted) manufactured on (redacted).
During the inspection at their facility on June 9, 2022, they stated that after being notified of the potentially contaminated strawberries, they reviewed their production records to verify the implicated strawberries received were used only in the (redacted) and (redacted) juices. The firm also notified their processor who applies high pressure processing (HPP) as a treatment to produce the required minimum 5-log reduction, and they notified the produce supplier of the use of these strawberries in the (redacted) products.
The firm’s Hazard Analysis and HACCP plan for “Cold Pressed Beverages,” dated Sept. 30, 2021, did not identify hepatitis A as a hazard. In addition, their customer’s HPP process validation study that covers the juice products does not cover hepatitis A. However, they did not validate their HACCP plan before manufacturing subsequent lots of (redacted) and (redacted) on (redacted). For example:
- They did not evaluate/reassess the applicable HPP validation studies and critical limits after being notified, to determine if they were adequate to control for hepatitis A.
- They did not evaluate/reassess the effectiveness of their sanitation procedures to address the potential for cross contamination to other products. Their sanitation procedures for processing equipment such as the (redacted) and batch tanks only included a (redacted) rinse between pressing different fruits and vegetables and between processing different juices.
- They did not reassess their strawberry supplier to determine if they should discontinue use or implement additional measures at receiving. They received additional shipments containing strawberries from the same supplier on June 6, 2022, and June 27, 2022.
2. The firm’s written hazard analysis does not consist of an identification of food hazards and an identification of the control measures that can be applied.
a) Their hazard analysis for “Cold Pressed Beverages,” dated Sept. 30, 2021, identifies “Vegetative pathogens (Listeria, Salmonella, E. coli)” as potential hazards but does not identify any control measures to produce the required minimum 5-log reduction in the pertinent microorganism(s) in any of the juices and juice-based beverages that it covers.
b) They use fresh apples and frozen unpasteurized not from concentrate (NFC) apple juice in several of their blended juices/juice products. They have not identified Cryptosporidium parvum as a food hazard in their hazard analysis for their apple juice products. Also, they have not identified any controls for the hazard. Furthermore, the associated HPP validation study which was used to establish the critical limits for HPP processing only considered Listeria, E. coli O157:H7 and Salmonella spp. They manufactured “(redacted)” and “(redacted)?” juice product using fresh apples on (redacted).
3. The firm must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements that are both appropriate to the plant and the food being processed.
However, on June 9, 2022, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with CGMPs in the following areas:
A. The firm failed to monitor handwashing with sufficient frequency to ensure that hands are washed thoroughly at any time when the hands may have become soiled or contaminated. This is related to prevention of cross contamination from insanitary objects to food.
i. The employee who was setting up/assembling the (redacted) did not change gloves or wash hands prior to loading the conveyor at the (redacted) with celery stalks for the product, “(redacted).”
ii. The production manager did not wash his hands prior to donning gloves to enter production area to set up/stage bottles for the filler line. He put the disposable gloves over the cloth gloves he was wearing. He then grabbed these bottles to load the conveyor from the mouth of the bottle where his gloved fingers were touching the inside of the bottle.
B. The firm failed to monitor the conditions and practices during processing with sufficient frequency to ensure that building, fixtures, and other physical facilities of the plant are maintained in a clean and sanitary condition. This is related to prevention of cross contamination from insanitary objects to food.
i. An employee at the blending station used the employee hand washing station by the blending station to rinse a small bowl and a whisk used for mixing (redacted) used in the products, “(redacted)” and “(redacted).”
ii. A small plastic trash can for employees to dispose of gloves and paper towels at the hand washing station near the blending station was overfilled with trash. Strawberries were observed all over the floor around the trash can and red spots identified as liquid from discarded frozen strawberries were observed on the gloves located at the handwashing station. These gloves are for employee use during production.
iii. There was an open ceiling tile above the filler line where uncapped bottles were being conveyed to a carousel table.
iv. There was heavy dust build-up on power cords hanging off the ceiling above the open (redacted) and the open (redacted) that were in use.
v. There was a rusty pipe located directly above the (redacted).
4. The firm did not maintain sanitation standard operating procedure (SSOP) records that document the monitoring and corrections of conditions and practices during processing.
a) Their “Food Allergen Control” SOP BQP-03-D, states under the Sanitation section as follows: “(redacted).”
The production records for April 28, 2022, show they used staging tank (redacted) and the filler line to fill bottles of “(redacted)” product, which contains coconut water. The record shows that the following products that do not contain coconut were filled on the filler line after “(redacted) at (redacted) at (redacted) at (redacted) at (redacted). The “FILLER START-UP/CHANGEOVER CHECKLIST” used for monitoring the filler includes a box to be checked to “Verify Filler is Cleaned.” The form does not include fields to document the criteria (e.g., chemical concentration, temperature and time for treatments) required per their “Food Allergen Control” procedure. They stated they do not keep other records for monitoring the sanitation process between product changeovers.
Furthermore, the firm stated they conduct a verification step by collecting swabs to test for coconut allergen after cleaning and sanitation and prior to producing the next product without the coconut allergen. However, their “ALLERGEN TESTING LOCATIONS” record dated April 28, 2022, shows that swabbing was completed at (redacted). This time does not correspond with the production records that indicate at (redacted) their firm had already started filling the next product, “(redacted).”
b) The firm does not maintain Sanitation Standard Operating Procedure (SSOP) monitoring records for employee health conditions that could result in the microbial contamination of food.
Additional Comments:
The firm uses (redacted) in their “(redacted)” and “(redacted)” juice products. They identified the ingredient as a spice in their “Cold Pressed Beverages HACCP Plan.” In evaluating which food hazards are reasonably likely to occur, they did not consider the unapproved use of food or color additives. There is no regulation in 21 Code of Federal Regulation that permits the use of (redacted) as a direct food additive or color additive, and the FDA is not aware of a basis to conclude its use as an ingredient in food would be generally recognized as safe by qualified experts. Activated carbon is allowed for use in the manufacture of closure-sealing gaskets for food containers per; however, this is not applicable to their products as the (redacted) is directly added as an ingredient. Further, they have not assessed (redacted) for safety. Their ingredient supplier’s (redacted) product label states, “Do not consume at the same time as any medicines or other dietary supplement, as this may interfere with their effectiveness.” FDA has evaluated the use of (redacted) as an emetic poison treatment drug. FDA review found that while it may be used in high doses, it can adsorb other nutrients or medications; therefore, it can interfere with the consumer’s medications or dietary needs. Additionally, (redacted) can contain carcinogenic polyaromatic hydrocarbons and unsafe levels of heavy metals. Little is known about the safety of chronic consumption of (redacted).
If their use of (redacted) imparts color to these beverages, it meets the statutory definition of a color additive. Color additives are deemed unsafe unless their use conforms with a regulation listing the color additive and describing the conditions for its safe use. There is no regulation authorizing use of (redacted) as a color additive in food. Food that contains an unapproved color additive is deemed adulterated.
The full warning letter can be viewed here.
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