You should respond in writing within fifteen (15) working days from your receipt of this letter. 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 (21 U.S.C. You can find DWPE information relating to FSVP in Import Alert # 99-41, at. We may place the foods you import from the identified foreign supplier on detention without physical examination (DWPE) when you import the products. 381(a)(3)) to refuse admission of food products you import. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. Failure to adequately address this matter may result in further action. This letter notifies you of our concerns and provides you an opportunity to address them. 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. The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program.
STB GOV ISO
On February 25, 2021, you emailed our investigator a variety of documents for your tahini/sesame paste and sesame seed products, including certificates of analysis, ISO certificates, a Kosher certificate, and a HACCP certificate.
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Your significant violations of the FSVP regulation are as follows: We have not received your response to the Form FDA 483a.
![stb gov stb gov](https://yellow.place/file/image/cover/0/0/275/ajbbzlhqlbifqpmn.jpg)
Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.Īt the conclusion of the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations. You did not have FSVPs for these products. ĭuring the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for any of the foods you import from your foreign suppliers, including your tahini/sesame paste imported from your foreign supplier, (b)(4), located in (b)(4), and sesame seeds imported from your foreign supplier, (b)(4), located in (b)(4). 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. 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.
![stb gov stb gov](https://cdns.klimg.com/dream.co.id/resized/300x//real/2019/03/02/380967/stbgovsg.jpg)
384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L. This inspection was 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.
![stb gov stb gov](https://static.thairath.co.th/media/Dtbezn3nNUxytg04OMDiO9QPId7ay1wAwM71XBjozFDWbX.jpg)
STB GOV VERIFICATION
Issuing Office: Division of Northern Border Importsįrom February 1 to March 10, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for STB Quarters, LLC located at 4000 W.