- Delivery Method:
- Via Express Delivery
Recipient NameMr. Paisit Jittasirinuwat
Recipient TitleGeneral Manager/Owner
- TP. Food Canning Ltd., Part.
72 Moo 3 Tambol Mae Hia
Chiang Mai 50100
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740-3835
JAN 22, 2020
Reference No. 599159
Dear Mr. Jittasirinuwat:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) product facility, located at 72 Moo 3 Tambol Mae Hia, Klong-Cholpratan Rd., Chiang Mai 50100 Thailand on September 16-17, 2019. 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)) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 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. To date, we have not received a response with your corrective actions to the observations listed on the FDA-483.
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 of 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:
You must file the 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. Specifically, as noted during the inspection, your firm failed to file a scheduled process with FDA for your bamboo shoots in water packaged in cans and processed in (b)(4). However, to date our office has not received your process filings for the bamboo shoots you manufacture and ship to the United States.
Your firm did 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. We noted during the inspection that your firm has not established the critical parameters such as minimum time and temperature for processing bamboo shoot tips in water packaged in (b)(4) oz. cans in (b)(4). It appears the parameters used for processing the product in (b)(4). You promised to consult your process authority to validate the process in (b)(4) at the conclusion of the inspection. However, evidence of validation records such as temperature distribution or heat penetration data supporting the processing of bamboo shoots in (b)(4) has not been provided. We recommend that your firm work with a competent authority to develop and file the necessary scheduled processes for your low acid food operation.
Scheduled process information for low-acid foods processed by retort must be submitted on Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method) and low-acid foods controlled by water activity must be submitted on Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control 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 254le, 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. If you believe you have complied with FDA regulations, 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 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 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 email@example.com. Please reference 599159 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