- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMs. Sunit Kaur
- Banjaras Inc
2707 Gallion Dr.
Sugar Land, TX 77479-1979
- Issuing Office:
- Division of Southwest Imports
September 24, 2019
Re: CMS # 589115
Dear Ms. Kaur:
On August 21, 2017, the Food and Drug Administration conducted an Foreign Supplier Verification Program (FSVP) inspection at 2702 Galion Dr., Sugar Land, TX 77479-1979. We also conducted an inspection on July 10, 2019. This inspection was 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/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 were not in compliance with the requirements of 21 CFR part 1 subpart L for your coriander and garlic and Rasam powders from foreign supplier (b)(4)., your Kesar mango pulp from foreign supplier (b)(4), and your Suji rusk from foreign supplier (b)(4). Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.
However, we have not received your response to the Form FDA 483a.
Your significant violations are described below:
You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:
- Coriander with garlic manufactured by (b)(4) (e.g., entry #KM6- 3516695-2 line 21/3)
- Rasam powder manufactured by (b)(4) (e.g., entry # KM6- 3516695-2 line 101/1)
- Kesar mango pulp manufactured by (b)(4) (e.g., entry #KM6-3523053- 5 line 11/1)
- Suji rusk manufactured by (b)(4) (e.g., entry #KM6-3523668-0 Line 91/2)
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 implementing FSVP regulation in 21 CFR part 1 subpart L.
You 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 Coriander and garlic and Rasam powder manufactured by (b)(4); Kesar mango pulp manufactured by (b)(4); Suji rusk manufactured by (b)(4). We may place the foods on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP on Import Alert # 99-41, at https://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 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 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: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204.
If you have any questions regarding this letter, you may contact CO Santos via email at firstname.lastname@example.org. Please reference CMS #589115 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Division of Southwest Imports