WARNING LETTER
Roal Produce, Inc
MARCS-CMS 614061 —
July 27, 2021
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Alfonso Rojas
Recipient Title
Owner and Managing Director
Roal Produce, Inc
2520 Airline Dr.
Houston
,
TX
77009
United States
Issuing Office:
Division of Southwest Imports
United States
July 27, 2021
Re: CMS # 614061
Dear Mr. Rojas:
On February 25, March 3, and March 9, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of Roal Produce, Inc., located at 2520 Airline Drive, Houston, Texas 77009-1118. We also conducted an inspection on October 24-26, 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 the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for any of the foods you import from your foreign suppliers, including honey, ground pepper, and pumpkin seeds from supplier
(b)(4)
. You did not develop an FSVP for these products or for any of the products you import. 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 October 24-26, 2018 and the follow-up inspection on February 15, March 4, and March 9, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated March 18, 2021, which included general statements of assurance that you intend to comply with the FSVP requirements and need four months in order to develop your FSVPs. However, we are unable to evaluate the adequacy of your response as you did not provide any additional details or supporting documentation related to your FSVPs.
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 any of the foods you import, including the following foods:
Honey imported from
(b)(4)
Ground pepper imported from
(b)(4)
Pumpkin seeds 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.
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 for which you 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)).
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 will 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 the foods you import 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.
(b)(3)(A)
Please send your reply to Food and Drug Administration, Attention: Lisa Puttonen, Compliance Officer, the Division of Southwest Imports, 1201 Main Street Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, you may contact Lisa Puttonen via email at Lisa.puttonen@fda.hhs.gov. Please reference CMS # 614061 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/
Todd Cato
Program Division Director
Division of Southwest Imports
Content current as of:
12/07/2021
Regulated Product(s)
Food & Beverages