WARNING LETTER
Advance Nature Sdn Bhd
MARCS-CMS 686695 —
June 24, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Matthew Chin, CEO
Recipient Title
Joshua Choo, Business Director
Advance Nature Sdn Bhd
Lot 88, Perindustrian Senawang
2 Bunga
70450
Seremban
Selangor
Malaysia
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
Reference No. 686695
Dear Messrs. Chin and Choo:
The United States Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility located at Lot 88, Perindustrian Senawang, 2 Bunga, Seremban, Selangor, Malaysia 70450 on March 12 through March 14, 2024. Your firm aseptically packages low-acid bamnut milk. During the inspection, we found that your firm had serious deviations from the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation Part 113 (21 CFR 113) and the Emergency Permit Control regulation Part 108 (21 CFR 108). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm. We received your written response dated April 8, 2024. Our evaluation found your response was not adequate, as further described in this letter.
As a manufacturer of LACF products intended for export to the United States, 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 Parts 113. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 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 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). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF 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.
Your significant violations are as follows:
1. Your firm did not provide evidence that the scheduled processes for the low-acid food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in thermal processing requirements for low-acid foods in hermetically sealed containers, as required by 21 CFR 113.83. Specifically, your business director submitted heat sterilization processes for manufacturing of milk products in your scheduled process for bamnut milk. Your “BAMnut Milk” product is manufactured with the flour of bamnut, a legume. The product does not contain any dairy ingredients. Your firm did not have any documentation demonstrating a process authority had evaluated the filed scheduled process for “BAMnut Milk.” Furthermore, your business director does not have any training in the processing of low-acid canned foods.
Your response states you “
(b)(4)
.” You also state
(b)(4)
of bamnut into “BAMnut Milk,” but you did not provide those records as part of your response. Your response to this letter should include a letter from the Process Authority supporting their evaluation of your filed scheduled process for bamnut milk, heat penetration data, and temperature distribution studies supporting the filed critical parameters.
2. Your firm did not identify when your process deviated from the scheduled process, as required by 21 CFR 113.89. Specifically, your filed scheduled process lists a processing temperature of
(b)(4)
°C. However, during the inspection, our investigator reviewed your “UHT Daily Operation Record” for “Bamnut Milk” dated July 5, 2023, which demonstrates the UHT processing temperature was less than a
(b)(4)
°C for
(b)(4)
hourly recordings, with the UHT processing temperature as low as
(b)(4)
°C. You did not have these process deviations evaluated by a process authority.
Your response states you
(b)(4)
.” However, to date, you have not filed updated scheduled processes reflecting a lower processing temperature critical limit nor have you provided any documentation that a process authority has evaluated the batches manufactured at temperatures less than your filed critical temperature limit.
3. You did not record processing and production information for your aseptic processing and packaging system at the time it is observed, as required 21 CFR 113.100(a)(4). Specifically, the investigator reviewed your processing record, “UHT Daily Operation Record” dated July 5, 2023, for “Bamnut Milk” and your piping and instrumentation diagram (P&ID) for your aseptic processing system. The review of the processing record found that you are only recording the temperature at the outlet of the holding tube once per hour and you do not have a continuous temperature recording device (TRD) to capture the processing temperature. In addition, a review of your P&ID diagram found that your
(b)(4)
, therefore you are not recording the actual flow rate in the holding tube to ensure product receives the filed scheduled process. This information is critical to ensure the process has achieved a commercially sterile product.
Your response states you
(b)(4)
.” You have not provided any supporting documentation to demonstrate where the flow meter will be installed or that you are recording all necessary temperatures to ensure the product is rendered commercially sterile at the exit of the hold tube. Your response to this letter should provide a P&ID diagram demonstrating the locations of the temperature indicating device (TID), TRD, and flow meter and five-day consecutive days of monitoring records demonstrating you are manufacturing in accordance with your filed process.
4. You must have plant personnel involved in thermal processing systems or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with 21 CFR 113.10. Specifically, our inspection revealed no one at your firm has received training in critical factors in the production of LACF products nor aseptic processing.
Your response states you have enrolled your QA Personnel and Business Director to attend the online “Better Process Control School Full Certification.” You have not provided documentation demonstrating you have registered to attend or completed this training.
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 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. Responding in English will help to assist us in our review of your documentation.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF and acidified paste and sauce products under section 801(a) of the Act (21 U.S.C. 381(a)) including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, examples of Import Alerts that convey information specific to foreign firms that are not in compliance with the LACF food regulations (21 CFR 108 and 113) are Import Alert 99-37, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods without Filed Scheduled Processes and Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. These alerts can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113), and the current Good Manufacturing Practices regulation (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. If you do not believe your products are 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 686695 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Ann Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
11/26/2024
Regulated Product(s)
Food & Beverages