- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMaria I. Candelario
- Mexi-Land Inc.
150 Russell St.
City of Industry, CA 91744-3937
- Issuing Office:
- Division of West Coast Imports
November 24, 2020
Re: CMS # 610757
Dear Ms. Maria I. Candelario:
From July 20-29, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Mexi-Land Inc., located at 150 Russell St., City of Industry, CA 91744-3937. We also conducted an inspection on August 16, 2017. 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import, including but not limited to, soft candy tamarind flavor imported from (b)(4), located in Mexico, chocolate covered marshmallow lollipops imported from (b)(4), located in Mexico, and Enchilokas mango soft candy imported from (b)(4), located in Mexico. 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 August 16, 2017 and the follow-up inspection on July 29, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated August 4, 2020, in which you stated that you have hired a consultant to develop your FSVP. You stated that you would need 30 business days to complete the development of your FSVP. As of this date, we have not received any additional FSVP records from you.
Your significant violations of the FSVP regulation are as follows:
1. You must conduct a 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(a). Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During the inspection, you provided copies of your (b)(4) food safety plan for soft candy tamarind flavor, (b)(4) HACCP plan for chocolate covered marshmallow lollipops, and your foreign supplier (b)(4) HACCP plan for Enchilokas mango soft candy. However, for each of these, you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis, as required by 21 CFR 1.504(d).
2. You did not approve your foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). For example, for your foreign suppliers (b)(4) you did not evaluate your foreign supplier’s performance and the risk posed by the food in accordance with 21 CFR 1.505(a), approve your foreign supplier on the basis of this evaluation, and document your approval, as required by 21 CFR 1.505(b).
3. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 1.506(a)(1).
4. You did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d).
5. You did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). For example, you did not conduct and document (or obtain documentation of) one or more such supplier verification activities for your foreign supplier (b)(4) before importing soft candy tamarind flavor and periodically thereafter or for your foreign supplier (b)(4) before importing chocolate covered marshmallow lollipops and periodically thereafter. Furthermore, while you obtained a Certificate of Analysis for Enchilokas mango soft candy imported from (b)(4), which reported physicochemical and microbiological analysis for lot 7213, you did not document your review and assessment of these results, as required by 21 CFR 1.506(e)(3).
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 the food products you import. We may place the foods you import on detention without physical examination (DWPE) when you import the products. 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.
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: Deborah W. Hsu, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Deborah Hsu via email at firstname.lastname@example.org. Please reference CMS # 610757 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Acting Program Division Director
Division of West Coast Imports