WARNING LETTER
Rash Catering Services, LLC
MARCS-CMS 678976 —
April 22, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Rashida Abdul-Qadir
Recipient Title
Owner
Rash Catering Services, LLC
11430 Bissonnet St. Ste. B9
Houston
,
TX
77099-1965
United States
Issuing Office:
Division of Southwest Imports
One Main Place
201 Main Street Suite 7200
Dallas
,
TX
75202
United States
WARNING LETTER
April 22, 2024
Re:  CMS # 678976
Dear Ms. Abdul-Qadir,
On February 21-22, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Rash Catering Services LLC, located at 11430 Bissonnet St., Ste. B9., Houston, TX 77099-1965.  We also conducted a remote inspection on March 30-31, 2023. 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 the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.  We have not received your response to the Form FDA 483a issued on February 22, 2024.
Your significant violations of the FSVP regulation are as follows:
1.    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 foods you import, including each of the following foods:
•    Yam Flour, imported from
(b)(4)
, located in
(b)(4)
•    Plantain Flour, imported from
(b)(4)
, located in
(b)(4)
•    Biscuits, imported from
(b)(4)
, located in
(b)(4)
We note that you may meet the definition of a “very small importer” under 21 CFR 1.500.  If you meet the definition of a “very small importer” and choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required per 21 CFR 1.512(b)(1)(i).  You are also still required to comply with the requirements in sections 1.502, 1.503, and 1.509.  However, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510.  In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (see 21 CFR 1.512(b)(3)(i)).
In addition, although
(b)(4)
is declared at entry as the manufacturer for all of your imported products, during our inspection you told our investigator that you do not know who are the actual manufacturers of the products you import. The foreign supplier is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States, without further manufacturing/processing by another establishment, as defined in 21 CFR 1.500.
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 an opportunity to address them.  If you do not 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 you import which 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)).
In addition to the above, we offer the following comment:
According to information available to the FDA, you import seafood product, including but not limited to, Dried Eviscerated Panel Fish, Dried Smoke Cut Tilapia, and Dried Eviscerated Smoke Cut Stockfish.  In addition to the above requirements, if you intend to import seafood products, then you must operate in accordance with the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).  The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12.  More information can be found on FDA's website at: Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products, as found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-haccp-regulation-fish-and-fishery-products.
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 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 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Ernesto Barba, Compliance Officer, Division of Southwest Imports, 9725 Via de la Amistad, Ste 200, San Diego, CA 92154.  If you have any questions regarding this letter, you may contact Compliance Officer Ernesto S. Barba via email at Ernesto.Barba@fda.hhs.gov. Please reference CMS # 678976 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Director, Southwest Imports
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202
Content current as of:
05/21/2024
Regulated Product(s)
Food & Beverages