- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMs. Tae-Eun Kim
- Yakseon Food Agricultural Co. LTD
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740
FEB 11, 2020
Reference No. 600295
Dear Ms. Kim:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility located at 1306 Gyeongdong-ro, Andong-si, Gyeongsangbuk-do 36728, Republic of Korea on October 17-18, 2019. During that 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). At the conclusion of the inspection, the FDA investigator issued an FDA-483, lnspectional Observations that lists the serious deviations found at your firm. We acknowledge receipt of your response received November 7, 2019. Our evaluation revealed that this 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 firm has not established the critical parameters such as minimum time and temperature for processing in that you have not conducted temperature distribution, heat transfer rate, and heat distribution studies in your (b)(4) retort used for processing low-acid canned foods.
Your response states you will conduct the referenced studies. This response does not provide a timeframe for completion or identify the processing authority you will work with to establish the critical factors.
2. Your firm did not ensure your (b)(4) processing system, (b)(4) retort, was operated in a manner to ensure commercial sterility was achieved, as critical parameters were not measured and recorded at intervals of sufficient frequency to ensure they were within the limits specified in the scheduled process(es) for your low-acid canned foods as required by 21 CFR 113.400). Specifically, your (b)(4) retort does not have the following instrumentation: temperature-indicating device (TID), temperature recording chart, or mechanism to control (b)(4) mixture. The TID is the official process temperature and the temperature recording chart provides a continuous and permanent record of the temperatures inside the retort during the (b)(4) cycle. This temperature information is critical to ensure the process has achieved a commercially sterile product.
Your response states you will work with the retort company to equip your (b)(4) retort with the necessary devices to control the process, but you have not provided a timeframe for completion nor have you provided copies of invoices or work orders demonstrating this work has been scheduled or completed.
3. Your firm did not measure the initial temperature of the low-acid foods in their containers prior to processing to ensure the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, you stated (b)(4). Therefore, you are not capturing and documenting important processing information to ensure all the required information, including critical factors, are documented as specified in the scheduled process(es) and recorded as required by 21 CFR 113.100.
You response states you will determine the initial temperature of the LACF products prior to processing at sufficient frequency so that it is not below the minimum initial temperature in the scheduled process, but you have not identified how and at what frequency the initial temperature will be monitored, nor have you provided documentation you are recording the initial temperature. You must complete these corrective actions in order to comply with the production record requirements, per 21 CFR 113.100.
4. Your firm does not conduct any container integrity testing, visual or destructive on any products as required by 21 CFR 113.60.
Your response states you will conduct container integrity testing, but you have not provided any documentation describing the types of tests, frequency for which the tests will be performed, or how the tests will be documented.
5. 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.
Your response states you will attend a Better Process Control School in February 2020, but you have not provided documentation demonstrating you have registered to attend or completed this training.
In addition, we provide the following comment:
You must file your scheduled processes with the FDA for each low-acid food in each container size as required by 21 CFR 108.35(c)(2). This filing must occur not later than 60 days after registration and prior to the packing of a new product and include the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each product in each container size. On or about November 4, 2019, after the current inspection, FDA sent you a process inquiry for which we have not received a response. Your previously filed scheduled processes are no longer valid. Prior to shipping to the U.S., you should to ensure all scheduled processes are current and filed appropriately.
More information on registration and filing can be found in the publication "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format" available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for five lots of product produced over at least five days. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. 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.
Additionally, section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection- related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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 600295 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition