WARNING LETTER
Ya Ya Foods USA, LLC
MARCS-CMS 689733 —
September 24, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Yahya Abbas
Recipient Title
CEO
Ya Ya Foods USA, LLC
Kipling Ave #450-B
Toronto
ON
M8Z 5E1
Canada
yahya@yayafoods.com
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
September 24, 2024
WARNING LETTER
Ref: CMS Case # 689733
Dear Mr. Abbas:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility located at 450 Depot Drive, Ogden, UT 84404 on May 13 to May 16, 2024. The inspection covered your aseptically processed and packaged low-acid oat milk beverages. During our inspection, we found serious deviations from the Emergency Permit Control regulation [Title 21, Code of Federal Regulations (21 CFR Part 108)], and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, Title 21, Code of Federal Regulations (CFR), 21 CFR. Part 113 (21 CFR Part 113).
As a manufacturer of LACF products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113. Regulations specific to the processing of LACF products are described in 21 CFR Part 108 and 21 CFR Part 113. As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344). Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR Part 113 renders your low acid products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and LACF regulations through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations. You provided a written response to the inspectional findings on June 7, 2024, describing corrective actions planned or taken by your firm. You also provided updated responses on June 26, July 1, July 31, and August 13, 2024. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address your response below.
Your significant deviations are as follows:
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, (21 CFR Part 113)
1. You did not identify deviations from the scheduled process or critical factors, which were out of control, as required by 21 CFR 113.89. Specifically, during the inspection, our investigators observed multiple instances where the temperature of the sterile seals or barriers
(b)(4)
of the aseptic
(b)(4)
were below the critical parameter of
(b)(4)
and the boiling point of water
(b)(4)
, including at the aseptic surge tank.
For example, on May 14, 2024, during the production of Oatly Barista Oat Milk, Lot
(b)(4)
, operators recorded the temperature of the steam barriers for the aseptic surge tank, temperature sensor
(b)(4)
, dropping to
(b)(4)
and our investigator observed the
(b)(4)
temperature of 115.6°F at 11:10. A review of the temperature sensor data for
(b)(4)
from April 22 to May 15, 2024 identified multiple instances where the temperature dropped consistently below
(b)(4)
during the production of at least
(b)(4)
batches of Oat Milk:
(b)(4)
. In addition, on May 16, 2024, during the production of Oatly Oat Milk Original, the temperature for the steam barriers on the aseptic
(b)(4)
, temperature
(b)(4)
, were
(b)(4)
, at 11:09 as displayed on the
(b)(4)
of the aseptic system. You began aseptic filling and packaging at
(b)(4)
.
Furthermore, when our investigators discussed the loss of steam on the steam seals and barriers, you stated you were in the middle of a large plant expansion, including the addition of new
(b)(4)
, surge tanks, fillers, and upstream processing equipment. Your Plant Director stated that the plant’s steam demand often exceeds the steam supply. He stated you had ordered a new boiler which was expected to be operational by the end of the summer 2024.
In your response dated June 7, 2024, you stated the fluctuating steam supply on the surge tank was due to the failure of a lock nut on the pressure reducing valve. Your corrective action was to increase the steam supply pressure to
(b)(4)
and tighten the locknut on the pressure reducing valve. You stated no steam fluctuations have been observed since you completed the corrective actions. You also identified a clog in the steam line filter to be the reason for temperatures on the homogenizer steam barriers being below
(b)(4)
and that after cleaning the steam line filter the temperatures have been maintained
(b)(4)
. We also note that in your response dated July 1, 2024, you stated your Process Authority defined the critical value for the homogenizer steam barriers as
(b)(4)
and you have revised your monitoring records to capture this change. You also implemented continuous monitoring of
(b)(4)
as part of your product release criteria and added steam line filter cleaning to your preventive maintenance program. In your response dated July 31, 2024, you provided a letter from your Process Authority regarding the agitator steam barrier deviation, which included a review of production critical factors and determined “all other critical factors were maintained within limits and no deviations were observed.” The over-pressure on the agitator steam barrier was within or exceeded specification during all production and sterile maintenance periods from April 21 to May 16, 2024. Your Process Authority concluded the food safety risk is mitigated by the overpressure when the temperature fluctuates below
(b)(4)
. We will verify the adequacy of your corrective actions during our next inspection.
In addition, we request you provide an update on your facility expansion and ability to provide sufficient steam during aseptic processing to ensure finished product is commercially sterile in your response to this letter.
2. During aseptic processing, you must record measurements demonstrating the proper performance of steam seals or other similar devices at intervals of sufficient frequency to ensure that the critical values established in the scheduled process are met, as required by 21 CFR 113.40(g)(1)(ii)(E). Specifically, you were not monitoring critical factors related to the maintenance of sterility of the aseptic surge tank and steam barriers on the
(b)(4)
of the aseptic
(b)(4)
, including the aseptic
(b)(4)
.
For example, a review of the batch records dated April 25 – 26, 2024, found the hand recorded temperature values for temperature
(b)(4)
on the “Aseptic Holding Tank (AHT) Monitoring Record” during the production of Oatly Barista Oat Milk, to be
(b)(4)
. In addition, a review of the batch records dated May 7 – 9, 2024, found the hand recorded temperature values for temperature
(b)(4)
on the “Aseptic Holding Tank (AHT) Monitoring Record” during the production of Oatly Barista Oat Milk, to be
(b)(4)
. However, the
(b)(4)
recording charts for the aseptic tank included in the batch records do not include any records or monitoring information for
(b)(4)
to demonstrate the steam barriers are being continuously monitored. None of these critical steam seals or barriers are currently tracked and trended to ensure that steam is present in critical steam seals or steam barriers. Equipment downstream from the
(b)(4)
that may be subject to potential entry of microorganisms into product should be equipped with steam seals or other effective barriers at the potential access points and their performance should be monitored during operations to ensure aseptic conditions are maintained through filling and packaging.
In your response dated July 1, 2024, you stated your investigation determined that all critical factors are being
(b)(4)
and the electronic records are reviewed by your Finished Product Release Coordinator prior to release of the product; however, your staff neglected to ensure printed/signed QC view records were included in the batch records prior to product release. However, you did not provide any supporting documentation demonstrating that the critical factors were continuously monitored or reviewed for batches previously released into interstate commerce. In addition, you stated you trained your staff to print and review your
(b)(4)
records associated with the monitoring of these critical factors and the release of a batch of finished product. You provided completed training records for continuous trend reviews and batch release. You also provided printouts from the system demonstrating you can generate and review the electronic real time measurements of the critical parameters. However, you did not provide completed records demonstrating the implementation of this review and release process. We will verify the adequacy and implementation of this corrective action during our next inspection.
3. You did not ensure that that the graduations on the y-axis of your temperature recording device did not exceed
(b)(4)
within a range of
(b)(4)
of the process temperature, as required by 21 CFR 113.40(g)(1)(i)(B)(1). Specifically, you recorded all your critical factors for your
(b)(4)
and aseptic surge tank using a
(b)(4)
recording chart. The critical temperatures monitored by the
(b)(4)
are the
(b)(4)
. In practice, you told our investigators that you
(b)(4)
. However, the temperature ranges on the
(b)(4)
on the printed temperature chart exceed regulatory requirements and there was not enough resolution to determine if the scheduled process temperatures were met for the following batches: Oatly Barista Oat Milk, Lots
(b)(4)
and Oatly Barista Oat Milk, Lots
(b)(4)
.
In your response dated June 7, 2024, you stated you will revise your written procedure “
(b)(4)
Historian User Guideline (105-QC-W)” to specify the scaling required for printed temperature records and provide training on how to print the
(b)(4)
records in the scaling required by FDA regulation. You stated you planned to complete this corrective action by July 31, 2024. However, you have not provided implementation records for this corrective action. We will verify the adequacy and implementation of this corrective action during our next inspection.
4. You did not have a qualified representative of plant management review all processing and production records for completeness and to ensure that the aseptic low-acid food product received the scheduled process, which 21 CFR 113.100(b) requires be done not later than one working day after the actual process, and before shipment or release for distribution. The records must also be signed or initialed and dated by the reviewer. 21 CFR 113.100(b). From at least March 1, 2024, through the inspection date of May 16, 2024, you did not document a review of critical factors for the aseptic filling and packaging of Oatly Barista Oat Milk identified in
(b)(4)
(e.g., Aseptic Chamber Temp (AC Temp), Aseptic Chamber Pressure (AC Pres), and Filler speed) for your aseptic packaging operations on your
(b)(4)
to ensure the product received the scheduled process. Specifically, you use a
(b)(4)
recording chart to record the critical factors for the aseptic filling and packaging of your finished product. However, you did not document your review of the filling data recorded from your
(b)(4)
recording chart for Oatly Barista Oat Milk
(b)(4)
. Furthermore, you did not print out the data from your
(b)(4)
recording chart to include in your finished product batch records. You told our investigator that you are continuously monitoring the critical factors on the
(b)(4)
system display panel and record that information periodically on the batch record but did not document your review of the information.
In your response dated June 7, 2024, you stated you determined all the filling critical factors were being continuously monitored via the
(b)(4)
and the
(b)(4)
records were being reviewed as part of your finished product release process, but the printouts were not being including in the batch record with a documented review and approval as part of the finished product release process. However, you did not provide any supporting documentation demonstrating that the critical factors were continuously monitored or reviewed for batches previously released into interstate commerce. You stated additional training will be provided to ensure the
(b)(4)
records are printed and reviewed for the critical factors and the review will be verified on your newly created “Finished Product Review Checklist.” You also committed to providing additional personnel resources to accommodate the review requirements and support future growth. While you provided documentation of additional personnel and your written procedure, you did not provide completed records demonstrating the implementation of this review and release process. We will verify the adequacy and implementation of this corrective action during our next inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction.
In addition, we offer the following comment:
You are responsible for also ensuring that your processing plant operates in compliance with the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B) and you have a responsibility to use procedures to prevent violations of the Act and all applicable regulations.
If finished product microbiological testing is being conducted on products that must be commercially sterile (i.e., LACF products), appropriate quality control operations must be used to ensure that food is suitable for human consumption, as required by 21 CFR 117.80(a)(2). During our inspection, you were using a third-party validated adenosine triphosphate (ATP) test method as a finished product microbiological release test. Your validated test method established a bioluminescence threshold of background microflora in your LACF product as
(b)(4)
’relative light units’ (RLU). Although
(b)(4)
was your established release limit, in practice, our investigator identified multiple occasions in May 2024 where finished product was released with ATP test results above the established limit and up to
(b)(4)
. Your justification for releasing product with results greater than
(b)(4)
limit appeared to be primarily based on an average of your internal sample results since implementing ATP testing without any justification that these results are indicative of commercial sterility. You also told our investigators that your practice was to re-run a suspect or positive sample immediately after an ATP failure by testing the same sample again and if the test result was acceptable then finished product could be released. However, you did not provide any justification for this practice.
In your response dated June 7, 2024, you stated you would be transitioning to standard plate count testing for microbiological finished product testing. However, you did not provide any documentation supporting that the finished products released with a RLU limit above
(b)(4)
were commercially sterile and did not present a public health concern. We recommend you have your Process Authority evaluate your finished product lots released with ATP levels greater than
(b)(4)
and still within shelf-life to ensure the products are commercially sterile and are not a public health concern. In addition, FDA recommends that any microbiological failures be treated as process deviations as they may be indicative that the product did not receive its scheduled process or was contaminated after processing.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Victoria Wagoner, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Victoria Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference 689733 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
cc:
Damon Hooker, Plant Director
450 Depot Dr.
Ogden, UT 84404
damon.hooker@yayafoods.com
Content current as of:
10/15/2024
Regulated Product(s)
Food & Beverages