- Food & Beverages
Recipient NameMr. Tang Hang Seng
Recipient TitleManaging Director
- Suntraco Food Industries SDN BHD
- Suntraco Food Industries SDN BHD
No. 1 & 3 JLN Korporat 3KU9
Taman Perindustrian Neru
42200 Klang, Selangor
- Issuing Office:
- Center for Food Safety and Applied Nutrition
FEB 8, 2018
VIA EXPRESS DELIVERY
Mr. Tang Hang Seng, Managing Director
Suntraco Food Industries SDN BHD
No. 1 & 3 JLN Korporat 3KU9
Taman Perindustrian Neru
Klang, Selangor, 42200
Reference No. 545371
Dear Mr. Seng:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) and acidified food product facility located at No. 1 & 3 JLN Korporat 3KU9 Taman Perindustrian Neru, Klang, Selangor, Malaysia on September 28-29, 2017. 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 108)); the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation Part 113 (21 CFR 113); and the Acidified Foods regulation Part 114 (21 CFR 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 acknowledge receipt of your response received via email on October 13, 2017. Our evaluation revealed that this response was not adequate, as further described in this letter.
As a manufacturer of LACF and acidified food 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 and 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 thermally processed low-acid foods packaged in hermetically sealed containers and acidified food products whenever a processor has failed to fulfill the requirements of 21 CFR 108.25 and 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113 and 114. Regulations specific to the processing of LACF and acidified food products are described in 21 CFR 108, 21 CFR 113 and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, 21 CFR 108.35, 21 CFR 113, and 21 CFR 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) and 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 108.25, 21 CFR 108.35, 21 CFR 113, and 21 CFR 114 renders your LACF and 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, Acidified regulations, and LACF regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
- You must file the scheduled processes with the FDA for each acidified food and each low-acid food in each container size to comply with 21 CFR 108.25(c)(2) and 21 CFR 108.35(c)(2). These filings must occur not later than 60 days after registration and prior to the packing of a new product. For acidified products these must include conditions for heat processing; control of pH, salt, sugar, and/or preservative levels; and source and date of the establishment of the process for each product in each container size. For LACF products, these must 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. Specifically, your firm failed to provide FDA with information and clarification regarding your scheduled processes. Letters were sent to your firm on August 11, 2016 for your Spicy Shrimp Sauce and on September 6, 2017 for your Paste for Chicken Curry, Paste for Vegetarian Curry, Paste for Rendang (Meat), and Spicy Sauce for Stir Fry products requesting this information and you failed to respond. Consequently, due to a lack of scheduled process information these processes are not considered filed with FDA (i.e., no valid scheduled processes on file). Further, the maximum pH values allowed in processing by your firm and pH values observed during review of your processing records exceeded the maximum pH values listed in the scheduled processes your firm initially attempted to file. You must ensure that you can adhere to the scheduled processes that you file. Also, you filed a process for Spicy Belacan Paste which the FDA considered to be an exempt product due to low water activity (Aw). However, based on review of your firm’s records, on April 28, 2017 the Aw was (b)(4) and on July 7, 2017 it was (b)(4) and (b)(4). If you cannot produce a product that consistently achieves an Aw of 0.85 or less, your product will lose its exemption status and will require a filed scheduled process with FDA.
Your response, dated October 13, 2017, states that you are searching to engage a process authority to help review and validate your processes and facilities to ensure compliance with US FDA regulations. However, to date, we have not received process filings for your Paste for Chicken Curry, Paste for Vegetarian Curry, Paste for Rendang (Meat), Spicy Sauce for Stir Fry, Spicy Shrimp Sauce, and Spicy Belacan Paste.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). 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.
- Further, your firm could not provide evidence that the scheduled processes for the low-acid and acidified 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 and in acidification and processing of acidified foods, as required by 21 CFR 114.83.
Your response, dated October 13, 2017, states that you are searching to engage a process authority to help review and validate your processes and facilities to ensure compliance with US FDA regulations. This response is inadequate because it does not demonstrate that you have corrected the deviation. To date, we received no further correspondence from your firm.
- You must exercise sufficient control including frequent testing so that the finished equilibrium pH values are not higher than 4.6 to comply with 21 CFR 114.80(a)(2). Specifically, the inspection revealed your firm collects (b)(4). This does not equate to sufficiently frequent testing in that you are not measuring the finished equilibrium pH of the product in its final container or at a defined time post production as established by a processing authority.
Your response, dated October 13, 2017, states that you will review the steps of measuring equilibrium pH values with a process authority. This response is inadequate because it does not demonstrate that you have corrected the deviation. To date, we received no further correspondence from your firm.
- You must have plant personnel involved in thermal processing systems, acidification, pH control, heat treatment, 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 and 21 CFR 1110. Specifically, our inspection revealed no one at your firm has received training in critical factors in the production of LACF products or pH controls and critical factors in acidification.
Your response, dated October 13, 2017, states that you plan enroll key staff to attend a Better Process Control School when a training in South East Asia is available. This response is inadequate because it does not demonstrate that you have corrected the deviation. To date, we received no further correspondence from your firm.
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 and acidified food regulations (21 CFR 108, 113 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 your facility operates in compliance with the Act and all applicable regulations, including the Acidified regulations (21 CFR 108 and 114), and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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: Kerry Kurdilla, 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 Kerry Kurdilla via email at Kerry.Kurdilla@fda.hhs.gov. Please reference 545371 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