- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMs. Sarah A. Jollay
- Bainbridge Beverage West, LLC
2335 Del Monte Street
West Sacramento, CA 95691-3806
- Issuing Office:
- Division of Human and Animal Food Operations West V
Dear Ms. Jollay:
The U.S Food and Drug Administration (FDA) inspected your juice manufacturing facility, located at 2335 Del Monte Street, West Sacramento, CA 95691 on June 9, 10, 22, 24, and 29, 2022. We found that you have serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120 renders the juice products 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)]. Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
To date, the agency has not received a written response from your firm regarding the violations noted on the Form FDA-483, Inspectional Observations, which was issued to your firm at the conclusion of the inspection.
The significant violations include the following:
1. You did not validate that your 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, as required by 21 CFR 120.11(b).
You were informed on June 1, 2022, that organic fresh strawberries (from “(b)(4)”) that you received were potentially contaminated with hepatitis A. You used these strawberries in the juice products (b)(4) and (b)(4) manufactured on (b)(4).
During the inspection at your facility on June 9, 2022, you stated that after being notified of the potentially contaminated strawberries, you reviewed your production records to verify the implicated strawberries received were used only in the (b)(4) and (b)(4) juices. You also notified your processor who applies high pressure processing (HPP) as a treatment to produce the required minimum 5-log reduction, and you notified the produce supplier of the use of these strawberries in the (b)(4) products.
Your Hazard Analysis and HACCP plan for “Cold Pressed Beverages,” dated September 30, 2021, did not identify hepatitis A as a hazard. In addition, your customer’s HPP process validation study that covers the juice products does not cover hepatitis A. However, you did not validate your HACCP plan before manufacturing subsequent lots of (b)(4) and (b)(4) on (b)(4). For example:
- You 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.
- You did not evaluate/reassess the effectiveness of your sanitation procedures to address the potential for cross contamination to other products. Your sanitation procedures for processing equipment such as the (b)(4) and batch tanks only included a (b)(4) rinse between pressing different fruits and vegetables and between processing different juices.
- You did not reassess your strawberry supplier to determine if you should discontinue use or implement additional measures at receiving. You received additional shipments containing strawberries from the same supplier on June 6, 2022 and June 27, 2022.
2. Your written hazard analysis does not consist of an identification of food hazards and an identification of the control measures that can be applied, as required by 21 CFR 120.7(a).
a) Your hazard analysis for “Cold Pressed Beverages,” dated September 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) You use fresh apples and frozen unpasteurized not from concentrate (NFC) apple juice in several of your blended juices/juice products. You have not identified Cryptosporidium parvum as a food hazard in your hazard analysis for your apple juice products. Also, you 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. You manufactured “(b)(4)” and “(b)(4)?” juice product using fresh apples on (b)(4).
3. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are both appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR 120.6(a)(1)-(8), to comply with 21 CFR 120.6(b).
However, on June 9, 2022 you 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. You 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, as required by 21 CFR 117.10(b)(3). This is related to prevention of cross contamination from insanitary objects to food, 21 CFR 120.6(a)(3).
i. The employee who was setting up/assembling the (b)(4) did not change gloves or wash hands prior to loading the conveyor at the (b)(4) with celery stalks for the product, “(b)(4).”
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. You 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 as required by 21 CFR 117.35(a). This is related to prevention of cross contamination from insanitary objects to food, 21 CFR 120.6(a)(3).
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 (b)(4) used in the products, “(b)(4)” and “(b)(4).”
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 (b)(4) and the open (b)(4) that were in use.
v. There was a rusty pipe located directly above the (b)(4).
4. You did not maintain sanitation standard operating procedure (SSOP) records that document the monitoring and corrections of conditions and practices during processing, as required per 21 CFR 120.6(c).
a) Your “Food Allergen Control” SOP BQP-03-D, states under the Sanitation section as follows: “(b)(4).”
The production records for April 28, 2022 show you used staging tank (b)(4) and the filler line to fill bottles of “(b)(4)” product, which contains coconut water. The record shows that the following products that do not contain coconut were filled on the filler line after “(b)(4) at (b)(4) at (b)(4) at (b)(4) at (b)(4). 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 your “Food Allergen Control” procedure. You stated you do not keep other records for monitoring the sanitation process between product changeovers.
Furthermore, you stated you 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, your “ALLERGEN TESTING LOCATIONS” record dated April 28, 2022, shows that swabbing was completed at (b)(4). This time does not correspond with the production records that indicate at (b)(4) your firm had already started filling the next product, “(b)(4).”
b) You do not maintain SSOP monitoring records for employee health conditions that could result in the microbial contamination of food.
You use (b)(4) in your “(b)(4)” and “(b)(4)” juice products. You identified the ingredient as a spice in your “Cold Pressed Beverages HACCP Plan.” In evaluating which food hazards are reasonably likely to occur, you did not consider the unapproved use of food or color additives as required per 21 CFR 120.7(c). There is no regulation in 21 Code of Federal Regulation that permits the use of (b)(4) as a direct food additive or color additive, and we are 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 21 CFR 177.1210; however, this is not applicable to your products as the (b)(4) is directly added as an ingredient. Further, you have not assessed (b)(4) for safety. Your ingredient supplier’s (b)(4) 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 (b)(4) as an emetic poison treatment drug. Our 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, (b)(4) can contain carcinogenic polyaromatic hydrocarbons and unsafe levels of heavy metals. Little is known about the safety of chronic consumption of (b)(4).
If your use of (b)(4) imparts color to these beverages, it meets the statutory definition of a color additive at section 201(t) of the FD&C Act [21 U.S.C. § 321(t)]. Color additives are deemed unsafe unless their use conforms with a regulation listing the color additive and describing the conditions for its safe use (section 721(a) of the FD&C Act) [21 U.S.C. § 379e(a)]. There is no regulation authorizing use of (b)(4) as a color additive in food. Food that contains an unapproved color additive is deemed adulterated (section 402(c) of the FD&C Act) [21 U.S.C. § 342(c)].
The violations in this letter are not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify this office in writing within 15 working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 638942 when replying.
If you prefer to send your response electronically, please email it to: ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and CMS# 638942 number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at firstname.lastname@example.org or (949) 608-2967.
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
CC: Bainbridge Beverage West, LLC
PO Box 938
Coloma, MI 49038-0938