- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMs. Clara White
- White Trading Corporation
802 South Sherman Street
Longmont, CO 80501
- Issuing Office:
- Division of Southwest Imports
December 15, 2020
Re: CMS # 611251
Dear Ms. White:
From July 21 to July 31, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Programs (FSVP) inspection of FSVP records that you submitted to FDA electronically for White Trading Corporation, Longmont, CO 80501. We also conducted an inspection on May 1, 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 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: (b)(4) Cheese imported from (b)(4). Based on your import shipping history, you import a variety of cheeses from multiple foreign suppliers (b)(4). Your firm did not have an FSVP in place for (b)(4) Cheese or for any 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 both the most recent inspection on July 31, 2020 and the initial inspection on May 1, 2018, our investigator provided you, in each instance, with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your emailed response dated August 21, 2020, where you indicated that you had collected documentation from all but one of your foreign suppliers in order to meet your FSVP requirements. You stated that development of your FSVP procedures and documentation processes was close to completion and should be completed within the next 30 days. You indicated you would share what you had developed with FDA. Despite contacting you to follow up on September 17, 2020, to date, we have not received any documentation from you.
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 a FSVP for the foods you import, including but not limited to, (b)(4) Cheese 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.
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 your products 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 and any questions regarding this letter and reference CMS # 611251 on any documents or records you send to Food and Drug Administration, Attention: Zumera B. Ajani, Compliance Officer, 1201 Main Street, Suite 7200; Dallas, TX 75202.
Program Division Director
Division of Southwest Imports