- Delivery Method:
- VIA EMAIL AND UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Vinai Kulnarong
- V-Nine Inc.
2130 Beaver Road
Hyattsville, MD 20785
- Issuing Office:
- Division of Northeast Imports
CMS # 609647
Dear Mr. Kulnarong:
On June 10 and 29, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm V-Nine Inc., located at 2130 Beaver Road, Hyattsville, Maryland. We also conducted an inspection on April 10 and 18, 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 the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your pad thai sauce imported from (b)(4), located in (b)(4). You did not have an FSVP for this product. Additionally, 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 your jasmine rice imported from (b)(4). 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 April 18, 2018 and the follow-up FSVP inspection on June 29, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge your email response dated July 16, 2020 where you informed us that you were in the process of developing your FSVP.
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 your pad thai sauce imported from (b)(4).
2. You did not meet the requirements to conduct a hazard analysis for the products you import in accordance with 21 CFR 1.504. Specifically, for your jasmine rice imported from (b)(4), while you obtained a hazard analysis from your foreign supplier, you did not document your review and assessment of your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).
3. You did not meet the requirements to evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505. You must 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 yur approval, as required by 21 CFR 1.505(b). You did not document your approval of your foreign supplier of jasmine rice imported from (b)(4), as required by 21 CFR 1.505(b).
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for foods you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for the jasmine rice imported from your foreign supplier, (b)(4). For your jasmine rice imported from (b)(4), while you obtained audit certificates, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b) and you did not document your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d).
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: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) firstname.lastname@example.org. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at email@example.com. Please reference CMS # 609647 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