WARNING LETTER
Lucero Produce II Corp.
MARCS-CMS 640910 —
October 26, 2022
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Olivia Lucero
Lucero Produce II Corp.
1250 Randall Avenue
Bronx
,
NY
10474
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
October 26, 2022
Re: CMS# 640910
Dear Ms. Olivia Lucero:
On July 12 through July 22, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Lucero Produce II Corp. located at 1250 Randall Avenue, Bronx, NY 10474. We also conducted inspections on August 28, 2018, and from January 4 to 20, 2021. 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-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 most recent inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your response on August 9, 2022, in which you stated that you needed more time to provide the appropriate documentation. As of the date of this letter, we have not received any additional response or documents. We are unable to evaluate the adequacy of your response because you did not provide any additional details or documentation demonstrating you have implemented any corrective action to comply with the FSVP regulation.
Your significant violation of the FSVP regulation is 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, maintain, and follow an FSVP for any of the foods you import, including each of the following:
Papalos, Epazote and Pipachas imported from
(b)(4)
located in
(b)(4)
You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your 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 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
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.
(b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A)
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 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 Food and Drug Administration, Attention: Feryal Ahmad, Compliance Officer, Division of Northeast Imports, ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Feryal.Ahmad@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ahmad via email at Feryal.Ahmad@fda.hhs.gov. Please reference CMS# 640910 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/
Anna Alexander
Acting Program Division Director
Division of Northeast Imports
Content current as of:
11/15/2022
Regulated Product(s)
Food & Beverages