WARNING LETTER
88 Special Sweet, Inc.
MARCS-CMS 607231 —
May 13, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Stella Sotoodeh
Recipient Title
CEO
88 Special Sweet, Inc.
2437 Lee Avenue
South El Monte
,
CA
91733-1407
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
May 13, 2020
Re: CMS # 607231
Dear Ms. Sotoodeh:
On January 9 and 21, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at 88 Special Sweet, Inc., 2437 Lee Avenue, South El Monte, CA 91733. We also conducted an inspection on September 13, 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/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verificationprograms-fsvp-importers-food-humans-and-animals.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import, including your Sunny Popping Balls (Boba) Strawberry Flavor, imported from your foreign supplier
(b)(4)
, and your Mango Syrup and Passion Fruit Jam, imported from your foreign supplier
(b)(4)
. Because of these significant violations, your firm is not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on September 13, 2018 and the follow-up inspection on January 9 and 21, 2020, our investigator provided you 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 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:
• Sunny Popping Balls (Boba) Strawberry Flavor products imported from
(b)(4)
.
• Mango Syrup and Passion Fruit Jam products imported from
(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 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 Sunny Popping Balls (Boba) Strawberry Flavor, imported from foreign supplier
(b)(4)
, and Mango Syrup and Passion Fruit Jam, imported from foreign supplier
(b)(4)
. We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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 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: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 607231 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:
05/26/2020
Regulated Product(s)
Food & Beverages