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  5. Campimex, Inc. - 610730 - 12/11/2020
  1. Warning Letters

WARNING LETTER

Campimex, Inc. MARCS-CMS 610730 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Arturo Tejeda
Recipient Title
Owner
Campimex, Inc.

3117 South Casa Linda Street
McAllen, TX 78503
United States

Issuing Office:
Division of Southwest Imports

United States

Dear Mr. Tejeda:

On June 30, 2020 and July 2, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection of FSVP records that you submitted to FDA electronically.  We also conducted an inspection on July 10, 2018.  This inspection was 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 your FSVPs for Frozen Sliced Strawberries from manufacturer (b)(4), (b)(4).  We found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the documents you presented as your FSVP for this product.  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 July 10, 2018, and the follow-up inspection on July 2, 2020, our investigator provided you with Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a.

Your significant violations of the FSVP regulations are as follows:

  1. You must conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504.  Your hazard analysis identified and evaluated hazards that may be present from the point after your suppliers load and ship the products you import, including Frozen Sliced Strawberries from (b)(4). However, you did not identify or evaluate biological, chemical or physical hazards that may be present before your suppliers load the products you import. We note that having a complete hazard analysis is essential to conducting a proper evaluation of your foreign supplier under 1.505 and determining and conducting appropriate verification activities under 1.506.
  2. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on your evaluation conducted to determine a foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505, and document your use of these procedures as required by 21 CFR 1.506(a)(1).
  3. You did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import, as required by 21 CFR 1.506(b).

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 Frozen Sliced Strawberries from manufacturer (b)(4).  We may place the food from the identified foreign supplier on detention without physical examination (DWPE) when you import the product.  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.

In addition to the above violations, we also have the following comments: We note that under 21 CFR 1.501(b)(1), 21 CFR part 1 subpart L does not apply with respect to juice products that are imported from a foreign supplier that is required to comply with, and is in compliance with, the requirements in 21 CFR part 120.  If you import juice products that are subject to 21 CFR part 120, you must comply with the requirements applicable to importers of those products under 21 CFR 120.14.  Based on the documents you provided during our FSVP inspection it appears you are not in compliance with 21 CFR 120.14 because you did not have and implement written procedures for ensuring that the juice you import into the United States was processed in accordance with the requirements of 21 CFR part 120 with respect to your juice product Frozen Mango Pulp imported from your foreign supplier, (b)(4).

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 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 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: Lisa M 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 M Puttonen via email at Lisa.puttonen@fda.hhs.gov.  Please reference CMS #610730 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
District Director
Division of Southwest Imports

 
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