- Delivery Method:
- VIA EMAIL AND UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameLorenzo Pina
- Global Trade Bridge Corporation
30 Wall Street 8th floor
New York, NY 10005
- Issuing Office:
- Division of Northeast Imports
CMS # 612898
Dear Mr. Pina:
On December 15 - 23, 2020, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically. We also conducted an inspection on September 11, 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 FSVP implementing 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 sugar you import from (b)(4) you import from (b)(4); garlic paste imported from (b)(4) soda crackers imported (b)(4); and cassava bread imported (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 FSVP inspection on December 23, 2020, our investigator provided you with a Form FDA 483a FSVP Observations. To date, we have not received your response to the Form FDA 483a issued on December 23, 2020.
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, you did not develop an FSVP for the sugar you import from (b)(4) and the virgin coconut oil you import from (b)(4).
2. 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)). You provided a copy of your foreign supplier (b)(4) hazard analysis for cassava bread and your foreign supplier (b)(4) hazard analysis for garlic paste; however, you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis for either of these foods or that the hazard analysis for the garlic paste was conducted by a qualified individual, as required by 21 CFR 1.504(d).
3. 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 and documented in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). Specifically, for your foreign supplier (b)(4) you provided standard operating procedures (SOPs), a hazard analysis, and temperature monitoring records, and for your foreign supplier (b)(4) you provided SOPs, a food safety plan, and temperature monitoring records; however, for both of these foreign suppliers, you did not provide documentation that you have evaluated your foreign supplier’s performance and risk posed by the food in accordance with 21 CFR 1.505(a), nor did you approve your foreign supplier on the basis of this evaluation and document your approval, as required by 21 CFR 1.505(b).
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). For example, your FSVP for soda crackers imported from your foreign supplier (b)(4) does not document which verification activity or activities listed in 1.506(d)(1)(ii)(A) through (D), 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). While you told our investigator that you visit your supplier manufacturing facilities and tour the plants yearly to make sure there are no issues, these visits are not documented in your FSVP.
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 address this matter adequately 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 sugar you import from (b)(4); virgin coconut oil you import from (b)(4), located in (b)(4); garlic paste imported from (b)(4), located in (b)(4); soda crackers imported from (b)(4), located in (b)(4); and cassava bread imported from (b)(4). We may place the foods you import from the identified foreign suppliers 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.
In addition to the above violations, we also have the following comment:
During the inspection you provided your FSVP for soda crackers imported from foreign supplier (b)(4). Included in the FSVP record were laboratory reports that were not legible. We remind you that all FSVP records must be legible, as required by 21 CFR 1.510(a)(3), as well as meet the other recordkeeping requirements under 21 CFR 1.510.
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 any 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 correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Pasquale Leone, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Pasquale.Leone@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Leone via email at Pasquale.Leone@fda.hhs.gov. Please reference CMS # 612898 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Program Division Director
Division of Northeast Imports