- Grandmas Food Products
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
SEPT 24, 2014
VIA EXPRESS DELIVERY
Ms. Jimi Raju, Proprietor
Grandmas Food Products
Perumballor, p.b. #31
Reference No. 437401
Dear Ms. Raju:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility located at Perumballor, p.b. #31, Muvattupuzha, Kerala, India on June 19-20, 2014. 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 Acidified Foods regulation (21 CFR 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, which lists the serious deviations found at the firm. We acknowledge receipt of your firm’s response to the FDA-483 received on July 23, 2014; 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 into the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and all applicable federal regulations. Regulations specific to the processing of acidified foods are described in 21 CFR 108, Emergency Permit Control and 21 CFR 114, Acidified Foods. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, including registration and filing of process information and the mandatory requirements of 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. In addition, 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 the acidified food regulations through links in FDA’s home page at www.fda.gov
Your significant violations are as follows:
- Your firm failed to provide FDA’s Center for Food Safety and Applied Nutrition (CFSAN), within 60 days after registration and before packing any new product, information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, 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, you do not have filed scheduled processes for your firm’s acidified food products, including but not limited to, curries (kaalan, pavakkai theeyal, ginger, pulissery, naranga) and bitter gourd pickle.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether products you manufacture are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108 and 114. Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication, “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm125439.htm
In addition, your firm did not register with FDA within 10 days of manufacturing acidified foods as required by 21 CFR 108.25(c)(1). Specifically, your firm is not registered with FDA as an acidified foods manufacturer. Your response letter included a statement that your firm had filed with the FDA as a Food Canning Establishment; however, the form you provided reflects that you updated your Food Facility Registration. You also must register with FDA as an acidified foods manufacturer to obtain a Food Canning Establishment (FCE) number, through the link provided above, in order to ship your acidified foods to the United States.
- You failed to establish scheduled processes of your acidified foods in accordance with 21 CFR 114.83. Specifically, you do not have scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83 for your firm’s acidified food.
- Your firm’s plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation are not under the operating supervision of a person who has attended a school approved by FDA, as required by 21 CFR 108.25(f). Specifically, no one at your manufacturing factory has received training in pH controls and critical factors in acidification.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your 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 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, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) is Import Alert #99-04. This alert can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Food regulations (21 CFR 108 and 114) and the 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 reinspection related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Catherine Vieweg, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Catherine.Vieweg@fda.hhs.gov
. Please reference #437401 on any submissions and within the subject line of any emails to us. You may also contact Catherine Vieweg via email if you have any questions about this letter.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
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