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  5. Dalai Biotech Company Ltd - 690671 - 09/30/2024
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WARNING LETTER

Dalai Biotech Company Ltd MARCS-CMS 690671 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Tseng C. Mei
Recipient Title
Chairman of the Board
Dalai Biotech Company Ltd

10 Minzhi Rd.
Tongluo Township, Miaoli County 366001
Taiwan

dalai@lailai3211.com.tw
Issuing Office:
Human Foods Program

United States

WARNING LETTER

Reference No. 690671

Dear Ms. Mei:

The United States Food and Drug Administration (FDA) inspected your acidified food facility located at 10 Minzhi Rd. Tongluo Township, Miaoli County, Taiwan 366001 on May 24 through May 27, 2024. During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). 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 June 11, 2024. Our evaluation found your response was not adequate, as further described in this letter.

As a manufacturer of thermally processed acidified foods intended for export to the United States (U.S.), you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of acidified food products. 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 acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration, and filing of process information, and the mandatory requirements in 21 CFR Part 114.

Regulations specific to the processing of acidified foods are described in 21 CFR Part 108 and 21 CFR Part 114. As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 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 108.25(j) 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 108.25 and 21 CFR 114 renders your acidified food 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 acidified food regulations through links in FDA’s home page at www.fda.gov.

Your significant violations are as follows:

1. A commercial processor of acidified foods must register as a food canning establishment and file a form FDA 2541 (food canning establishment registration) with the FDA within 10 days after first engaging in the manufacture, processing, or packing, as required by 21 CFR 108.25(c)(1), However, you did not register as a food canning establishment (FCE) before shipping your acidified fruit-flavored popping boba pearls to the U.S.

Your response did not address your lack of food canning establishment registration. As of September 10, 2024, you have not registered as a Food Canning Establishment although you continue to ship fruit-flavored boba pearls to the U.S. as recently as September 6, 2024. If you plan to continue shipping to the U.S., you must register as described above.

2. As a commercial processor engaged in the processing of acidified foods, you must provide the FDA information as to the scheduled processes, for each acidified food in each container size before shipping to the U.S., as required by 21 CFR 108.25(c)(2). As of the date of this letter, none of your firm’s acidified food scheduled processes have been filed with FDA. Scheduled process information for acidified foods must be submitted on Form FDA 2541e Food Process Filing for Acidified Method. Specifically, you manufacture ready-to-eat, shelf stable acidified popping boba pearls in various fruit flavors including, but not limited to strawberry, peach, and mango flavored popping boba pearls shipped to the U.S.; however, you have not filed a scheduled process for any of the boba pearls.

In addition, your manager told our investigator that you had not had a scheduled process for your shelf-stable boba pearls established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods, as required by 21 CFR 114.83. During the inspection, your manager explained that the ingredients are not weighed according to a recipe and there were no written recipes for the production staff to follow to ensure pH is consistent between batches. Your manager also stated he does not routinely test the pH. During the inspection, your manager measured the pH of boba pearls in the warehouse at random and found the pH to be (b)(4) for mango-flavored boba pearls shipped to the U.S. You must ensure that you are correctly measuring the finished equilibrium pH of the acidified boba pearls to ensure it is less than 4.6 and does not exceed the maximum equilibrium pH value as determined by a qualified person with expert knowledge as described above.

Your response included a summary of your planned and completed corrective actions including, developing “(b)(4),” enrolling personnel in HACCP certifications and acidic food courses within three months, and a 3rd party certification service conducting a product sterilization certification by the end of July 2024. You stated you would, upon completion of the certification, share the results of the certification with us. However, to date, you have not provided training records, third-party certifications, or evidence demonstrating you have had your scheduled processes for your shelf-stable boba pearls established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods (“process authority”), as required by 21 CFR 114.83. Nor have you filed your scheduled processes with us. In your response to this Warning Letter, you should provide the information regarding the qualified person who is collecting the scientific data to support your scheduled process if you intend to export acidified foods to the U.S. You should also provide information regarding your intent to file you scheduled processes established by a qualified individual as described above. You should also provide five (5) consecutive days of completed monitoring records demonstrating you are following your scheduled process established by a process authority to ensure you are meeting your established pH and thermal processing critical parameters.

In your response you also provided third-party test reports for Staphylococcus aureus, Salmonella, Listeria monocytogenes, and Aerobic Plate Count. While it is important to control these microorganisms, the main pathogen of concern in acidified foods is Clostridium botulinum (C. botulinum). C. botulinum is a bacterium commonly found in soil. It can produce a nerve toxin (botulinum toxin) under anaerobic conditions such as those in canned foods. Botulinum toxin can cause botulism, a rare but serious paralytic illness that can be fatal and is considered a medical emergency. In the case of acidified foods, you must control the finished equilibrium pH < 4.6 and ensure other spoilage organisms are not present such that they may grow in the product thereby resulting in a pH > 4.6. Furthermore, finished product testing alone is not sufficient to demonstrate acidified foods are safe for human consumption, you must also demonstrate you are in compliance with the Acidified Food regulations in 21 CFR Parts 108 and 114.

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 acidified food 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 acidified food regulations (21 CFR 108 and 114) 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 you operate in compliance with the Act and all applicable FDA regulations, including Acidified Foods regulation (21 CFR Part 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). For example, if you do resume exportation of acidified foods to the U.S. you must ensure you have adequate controls in place to ensure finished equilibrium pH < 4.6 and each container bears an identifying code to specify the establishment where the product was packed and the product contained within (21 CFR 114.80(a) and (b). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

We also offer the following comment in response to you telling our investigator that you do not export directly to the U.S. and do not know your U.S. consignees. You stated you ship to local distributors who ship to the U.S. FDA is aware of situations where adulterated foods manufactured in another country may be shipped illegally to the U.S. This is sometimes referred to as the “gray market.” Section 801(m)(1) of the Act (21 U.S.C. 381(m)(1)) states that prior notice must be submitted for the article of food and it must contain the identity of the manufacturer of the food being imported or offered for import. Accordingly, the automated commercial environment (ACE) filer must submit at the time of filing entry for an acidified food, the Food Canning Establishment Number (FCE) and the Submission Identifier (scheduled process number) and can dimensions or volume, as required by 21 CFR 1.73(c). We recommend that you inform your customers that your firm does not have an FCE, and your acidified food products do not have scheduled processes that have been filed with FDA, so there is no FCE or scheduled process number that can be provided in the prior notice. A failure to properly file an acidified food offered for import to the U.S. may result in the detention and refusal of the acidified food.

Please send your reply to the Food and Drug Administration via email to Victoria.Wagoner@fda.hhs.gov. If sending a response by mail address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (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 690671 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition

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