WARNING LETTER
La Serranita Import and Export LLC
MARCS-CMS 633743 —
September 19, 2022
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Hugo Enriquez
Recipient Title
Owner
La Serranita Import and Export LLC
618 Westfield Ave Apt 307
Elizabeth
,
NJ
07208
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS# 633743
Dear Mr. Hugo Enriquez:
On March 30 through April 13, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of La Serranita Import and Export LLC located at 618 Westfield Avenue, Apartment 307, Elizabeth, NJ 07208. We also conducted an inspection on April 9 through May 7, 2020. 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, including your frozen corn cobs imported from
(b)(4)
, located in
(b)(4)
; frozen whole yellow hot pepper imported from
(b)(4)
, located in
(b)(4)
; and special white cheese of Cayambe imported from
(b)(4)
, located in
(b)(4)
. 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 acknowledge receipt of your 483a Response on May 5, 2022, which included the following three documents:
1.
(b)(4)
2.
(b)(4)
3.
(b)(4)
“
(b)(4)
” appears to be a copy of the
(b)(3)(A)
for
(b)(4)
, located in
(b)(4)
.
(b)(4)
is in a language other than English. The document appears to be a certificate of analysis for frozen corn from a third-party laboratory for
(b)(4)
is in a language other than English. The document appears to be a certificate of analysis for frozen peppers from a third-party laboratory for
(b)(4)
. However,
(b)(4)
was not declared as the manufacturer for any foods covered during the inspection that concluded on April 13, 2022. Further, you did not provide any information about your review of these documents or how these documents would be used as part of an FSVP.
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 each of the following foods:
Frozen Corn Cobs imported from
(b)(4)
, located in
(b)(4)
Frozen Whole Yellow Hot Pepper imported from
(b)(4)
, located in
(b)(4)
Special White Cheese of Cayambe 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.
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 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
https://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. 321(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 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 address any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Russell Vandermark, FDA Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Russell.Vandermark@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vandermark via email at Russell.Vandermark@fda.hhs.gov. Please reference CMS # 633743 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/
CDR Joseph Tomao
Acting Program Division Director
Division of Northeast Imports
Content current as of:
11/29/2022
Regulated Product(s)
Food & Beverages