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  5. Sree Nidhi Corp - 634266 - 08/25/2022
  1. Warning Letters

WARNING LETTER

Sree Nidhi Corp MARCS-CMS 634266 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Ankitha Yalamanchili
Recipient Title
Manager
Sree Nidhi Corp

3301 Woodpark Blvd Ste D
Charlotte, NC 28206-4206
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

Dear Ms. Ankitha Yalamanchili: 

On April 14, through April 21, 2022, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Sree Nidhi Corp, located at 3301 Woodpark Blvd Ste D Charlotte, NC 28206. We also conducted an initial inspection on March 3, 2021.  These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L. 
  
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.  You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.  

At the conclusion of both inspections, our investigator provided you with a Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a. This is a repeated observation for which no corrective action plan has been offered to overcome the citation of your most recent 483a issued on April 21, 2022.    
    
Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the food products that you import, including:

• Karivepaku with Garlic Spices imported from (b)(4) located in (b)(4).
• Semolina Course Wheat imported from (b)(4) located in (b)(4).
• Maize Atta Corn Flour imported from (b)(4) located in (b)(4).
• Frozen Mango Slices imported from (b)(4) located in (b)(4).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements.  It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.  

This letter notifies you of our concerns and provides you with the opportunity to promptly correct the above violations.  If you do not adequately correct them, we may take further action.  For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805.  We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)). 

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations.  You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and state when you will correct any remaining violations. 

Please send your reply to Food and Drug Administration, Attention: Ms. Ruth Dixon, Program Division Director, Division of Southeast Imports, 404 BNA Drive, Building 200 - Suite 500 Nashville, TN 37217-2565.  If you have any questions regarding this letter, you may contact Ms. Coral del Mar Lopez, Compliance Officer via email at coraldelmar.lopez@fda.hhs.gov.  Please reference CMS #634266 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

 

Sincerely,
/S/
Ruth Dixon
For: Program Division Director
Division of Southeast Imports
 

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