Inspections, Compliance, Enforcement, and Criminal Investigations

Magadoo Corporation Co., Ltd. 10/6/17

 

  

Black HHS-Blue FDA Logo

 

5001 Campus Drive
College Park, MD 20740 

 
 

 

WARNING LETTER
OCT 6, 2017
 
VIA EXPRESS DELIVERY
 
 
Mr. Jaren Srichanil, Vice President
Magadoo Corporation Co., LTD
201 Rangsit-Nakornnayok 33 Road
T. Prachathipat
Thanyaburi, Pathum Thani, 12130
Thailand
 
Reference #: 538124
 
Dear Mr. Srichanil:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified food facility, located at 201 Rangsit-Nakornnayok 33 Road T. Prachathipat Thanyaburi, Pathum Thani, Thailand on August 21, 2017 and August 22, 2017. That inspection revealed you manufacture acidified food products. The inspection revealed serious violations of the regulations for Acidified Foods, Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108). That inspection resulted in FDA’s issuance of a FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email dated September 4, 2017, which included documentation describing production processes and details of your food products. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
 
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the 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 food products are described in 21 CFR 108 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 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) 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, Acidified Food regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations areas follows:
 
As a commercial processor of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm failed to file scheduled processes with FDA for your products, including but not limited to Indian Trumpet Fruit Pickle and Fig Pickle, which have been determined to be acidified food products.
 
In addition, a commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of acidified foods, as defined in section 201(a)(1) of the Act, to register and file a Form FDA 2541 (Food Canning Establishment Registration) with the FDA, as required by 21 CFR 108.25(c)(1). However, our inspection indicates that your firm processes acidified food products without being registered as a processor of acidified foods.
 
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.
 
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, such as proof of registration (FCE number) and a filed process(es) (SID numbers), or alternatively, justification as to why the products are exempt from requiring a filed process with supporting documentation. 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 do not respond or if we find your response inadequate, we may take further action. For instance, we may take further 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, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with 21 CFR is Import Alert 99-37 Detention Without Physical Examination of Low-Acid Canned Foods and Acidified Foods Without Filed Scheduled Processes. This alert can be found on FDA’s web site at: https://www.accessdata.fda.gov/cms_ia/importalert_1131.html
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Acidified Food 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 Food and Drug Administration, Attention Elizabeth A. DeGiglio Girard, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Elizabeth A. DeGiglio Girard via email at Elizabeth.Girard@fda.hhs.gov. Please reference CMS #538124 on any submissions and within the subject line of any emails to us. 
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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