My Habitat Brands LLC

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WARNING LETTER
CMS # 611996

February 3, 2021

Dear Mr. Gary Taneja:

From October 9 through October 21, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) for My Habitat Brands, LLC located at 601 Blossom Circle, Dayton, NJ. We also conducted an inspection on August 7, 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 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for food products that you import, including but not limited to chocolate bar and chocolate dairy mix imported from (b)(4) located in (b)(4) and botanas puffed snack imported from (b)(4) located in (b)(4). You 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 both the initial FSVP inspection on August 7, 2018 and the follow-up inspection on October 21, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your email response dated October 21, 2020, stating “Due to the Covid situation we (b)(4).” We also acknowledge receipt of your email response dated November 13, 2020, which included certificates you had just received from your foreign supplier, (b)(4) titled Food Safety System Certificate 22000, Health Certificate, and Halal certificate. We are unable to evaluate the adequacy of this response because you did not provide a record of your review of these documents or explain how they would apply to your FSVP program. You did not provide any documents from your supplier (b)(4).

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 each of the following foods:
• chocolate bar and chocolate dairy mix imported from (b)(4), located in (b)(4).
• botanas puffed snack 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.

You should take prompt action to correct any violations. If you do not promptly adequately address this matter, 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 that appear to be in violation of section 805. 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 any 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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) slater.bartlett@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at slater.bartlett@fda.hhs.gov. Please reference CMS # 611996 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/

Dawne Hines
Program Division Director
Division of Northeast Imports

 

CC: Gary Taneja, President
My Habitat Brands, LLC
566 7th Ave, 8th Floor Room 804
New York, NY 10018-1802

CC: Ravi Kommi, Manager
My Habitat Brands, LLC
601 Blossom Circle
Dayton, NJ 08810