Rajshree International, Inc.

WARNING LETTER Rajshree International, Inc. MARCS-CMS 606699 — May 04, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Food & Beverages Recipient: Recipient Name Shubh Prasad Recipient Title Owner Rajshree International, Inc. 12020 Woodruff Ave., Suite F Downey , CA 90241-5638 United States Issuing Office: Division of West Coast Imports United States WARNING LETTER May 4, 2020 Re: CMS # 606699 Dear Mr. Prasad: On March 6, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Rajshree International Inc, 12020 Woodruff Ave, Ste F, Downey, CA 90241-5638. We also conducted an inspection on September 10, 2018. 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 Foreign Supplier Verification Program (FSVP) implementing 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/GuidanceRegulation/FSMA/ucm361902.htm. During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your Ying Yaang Hakka Noodles imported from Frumar Marketing Pvt. Ltd., India and Lays Magic Masala imported from Pepsico India Holdings Pvt. Ltd., India. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection on September 10, 2018, and the follow-up inspection on March 6, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a. Your significant violations of the FSVP regulation are as follows: You did not develop, maintain, and follow an FSVP as required by the FSVP rule (21 CFR 1.502(a)). Specifically, your firm did not develop an FSVP for: Ying Yaang Hakka Noodles manufactured by Frumar Marketing Pvt. Ltd., India (e.g. B7P-0000823-1 Line 241/1) Lays Magic Masala manufactured by Pepsico India Holdings Pvt. Ltd., India (e.g., KM6-1532143-7 Line 31/1 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. In addition, FDA has determined that your facility located at 12020 Woodruff Ave, Ste F, Downey, CA 90241 is subject to the registration requirement in section 415 of the FD&C Act [21 U.S.C. § 350d] and our implementing regulations at 21 CFR Part 1, Subpart H. Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The failure of a food facility to renew its registration with FDA, as required by section 415(a)(3) of the FD&C Act, means that the facility has failed to register in accordance with section 415. Our records indicate that as of the date of this letter your firm does not have a valid food facility registration. The failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act [21 U.S.C. § 331(dd)]. As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilitiesand-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)). You should take prompt action to correct the above violations. If you do not promptly 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 products you import. We may place the foods you import on detention without physical examination (DWPE) when you import the products. 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. 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 revised 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 you 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 15 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: Dennis N. Hoang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS #600699 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/ Dan R. Solis Program Division Director Division of West Coast Imports Content current as of: 05/19/2020 Regulated Product(s) Food & Beverages