- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Hu Liu
- IDC USA INC
6619 18th Ave
Brooklyn, NY 11204-4315
- Issuing Office:
- Division of Northeast Imports
CMS # 613966
June 21, 2021
Dear Mr. Hu Liu:
On December 3, 2020, through February 24, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of IDC USA Inc. located at 6619 18th Ave Brooklyn, NY 11204. We also conducted an inspection on February 26, 2019. 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 inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your dried longan and dried (b)(4) dates imported from (b)(4) located in (b)(4) and dried fungus imported from (b)(4) in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
We acknowledge that during the most recent inspection you stated that you are (b)(4) and you provided our investigator with (b)(4), private laboratory analysis for shipments of dried (b)(4) dates and dried longan imported from (b)(4), a supplier evaluation questionnaire completed by (b)(4), a document stating that (b)(4) is a qualified supplier from January 2020 through December 2021 dated January 15, 2020, and written assurances from some of your foreign suppliers, including (b)(4), stating that their processes and procedures provide at least the same level of public health protection as FDA food safety regulations. However, the (b)(4) you provided show that your firm (b)(4).
At the conclusion of both the initial FSVP inspection on February 26, 2019, and the follow-up inspection on February 24, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We received your response to the initial inspection on March 10, 2019, which included documents related to dried mushrooms imported from (b)(4) located in (b)(4) and dried (b)(4) dates and herbal tea imported from (b)(4) located in (b)(4). The documents included a “Supplier Evaluation Questionnaire” for (b)(4) and (b)(4), as well as the hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan for dried shrimp and dried shellfish imported from (b)(4) and the hazard analysis and HACCP plan for dried mushroom (dried fungus) imported from (b)(4). You also provided analytical reports for entries of dried mushroom, dried shrimp, and dried (b)(4) dates. We acknowledged your response on September 6, 2019 and provided you some additional guidance. In general, these documents could be used as part of your FSVP, but you did not document your review and assessment of these documents. To date, we have not received your response to the Form FDA 483a issued on February 24, 2021.
Your significant violations of the FSVP regulation are 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, your firm did not develop an FSVP for your dried longan and dried (b)(4) dates imported from (b)(4) located in (b)(4).
2. You did not conduct a written hazard analysis for your dried fungus imported from (b)(4) located in (b)(4) to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504. We note that you may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis (21 CFR 1.504(d)). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements. With respect to your evaluation of a foreign supplier’s performance, you may rely on another entity’s evaluation, but that entity may not be the foreign supplier themselves, and you must document your review and assessment of the evaluation, as required under 21 CFR 1.505(d). In addition, you provided private laboratory analysis for shipments of dried (b)(4) dates imported from (b)(4) and dried longan imported from (b)(4). While sampling and testing of a food may be an appropriate supplier verification activity, the testing should be specific to the hazards being controlled, among other requirements (21 CFR 1.506).
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. Failure to adequately address this matter may result in 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 for which you appear to be in violation of section 805. We may place the foods you import from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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 will 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 correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Linda Ross, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) email@example.com. If you have any questions regarding this letter, you may contact Compliance Officer Ross via email at firstname.lastname@example.org. Please reference CMS # 613966 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 Northeast Imports