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Return-Path: <fis@fda.gov> Delivered-To: brodriguez@ifprc.com.pe Received: from pyme91.pymedns.net by pyme91.pymedns.net with LMTP id MLA5Iu2bdl8EVwAA++YgJQ (envelope-from <fis@fda.gov>) for <brodriguez@ifprc.com.pe>; Fri, 02 Oct 2020 00:18:05 -0300 Return-path: <fis@fda.gov> Envelope-to: brodriguez@ifprc.com.pe Delivery-date: Fri, 02 Oct 2020 00:18:05 -0300 Received: from ext-smtp.fda.gov ([150.148.19.44]:58696 helo=smtp7.fda.gov) by pyme91.pymedns.net with esmtps (TLS1.2) tls TLS_DHE_RSA_WITH_AES_256_GCM_SHA384 (Exim 4.93) (envelope-from <fis@fda.gov>) id 1kOBa2-0006Ak-Vx for brodriguez@ifprc.com.pe; Fri, 02 Oct 2020 00:18:05 -0300 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=fda.gov; i=@fda.gov; q=dns/txt; s=selector01; t=1601608679; x=1633144679; h=date:from:to:message-id:subject:mime-version: content-transfer-encoding; bh=hJcAM1R0pi1RYk3yuuZ+BfWXKLoWWMqBFqp5uQmIt4I=; b=OgUx9oN0b3twyBVTdGCoKFYV1J+WUYHgERpYxjdH6cer0STYYr46WwyN AJ0AnXrtL8yblXEg/x8FQCIUFwA5KZo2dM9z+3n4lviy7nvjW3/s1Ia+4 lE5tbQHQFS4b2C2kpUwZYEnQTQhSNZcjlsVEP5110c3vlZK6IsLqXaWmO U9l25Fev6pnPaPupea4qeu1xLJobCa6a+Z7sIihHQ2FESaN7EndtKBhQj k36TE9cVSPAdGlOXqwpr/1qV/mL87A9NsdSk/8fw3kp7igN/1Y/r+u2oQ 5TR1M20nwG5XnwVhJW/KmM6IYb/TxAtYDa2fyZgZC7wtPeYYUqNSoeDBB g==; IronPort-SDR: 3wX7Q6TnoaM/Cszf13KkapIlujZsk9Lr8Oh1I3WTvA7gT4e4VcyQON5zhHmEFhM7CU7j9f6tds M1WEblDHgIbQ== X-IronPort-Anti-Spam-Filtered: true X-IronPort-Anti-Spam-Result: =?us-ascii?q?A2H0DQB1mHZf/ygruQoZAkIDHAEBAQE?= =?us-ascii?q?BAQcBARIBAQQEAQFAB4FIAoEhEUEGgR+BNIQ9g0mRFJB3hjCBLD0LAQEBDgE?= =?us-ascii?q?TEgoEAQEChAREIIIZJjgTAgMBAQEDAgUBAQEFAQEBAQEBBQMBAgKGDDkMg1R?= =?us-ascii?q?GPAEBAQEBAQEBAQEBAQEBAQEBAQEBAQEBAQEBAQ8CCBo6GjQBSFQqDQIQAQQ?= =?us-ascii?q?BAQ8CWAQDE4JnQIMLh2WfWHaBMhqDaUtChUQJAYEEKgGBZIRnhn2CAIEQATa?= =?us-ascii?q?DGIJRCwOBFw0FARIBEBsCAQcJBAIQDAgUBII4gmAEkCSBEIkshyaVRotvhli?= =?us-ascii?q?LLIMOigGFKAOOYY44jVWBdYNqkToCAgICCQIVgWuBC3ArCkEPgyQJRxmOCVq?= =?us-ascii?q?BGoIggX+Ic1gCNQIGCgEBAwmOSAEB?= X-IPAS-Result: =?us-ascii?q?A2H0DQB1mHZf/ygruQoZAkIDHAEBAQEBAQcBARIBAQQEA?= =?us-ascii?q?QFAB4FIAoEhEUEGgR+BNIQ9g0mRFJB3hjCBLD0LAQEBDgETEgoEAQEChAREI?= =?us-ascii?q?IIZJjgTAgMBAQEDAgUBAQEFAQEBAQEBBQMBAgKGDDkMg1RGPAEBAQEBAQEBA?= =?us-ascii?q?QEBAQEBAQEBAQEBAQEBAQEBAQ8CCBo6GjQBSFQqDQIQAQQBAQ8CWAQDE4JnQ?= =?us-ascii?q?IMLh2WfWHaBMhqDaUtChUQJAYEEKgGBZIRnhn2CAIEQATaDGIJRCwOBFw0FA?= =?us-ascii?q?RIBEBsCAQcJBAIQDAgUBII4gmAEkCSBEIkshyaVRotvhliLLIMOigGFKAOOY?= =?us-ascii?q?Y44jVWBdYNqkToCAgICCQIVgWuBC3ArCkEPgyQJRxmOCVqBGoIggX+Ic1gCN?= =?us-ascii?q?QIGCgEBAwmOSAEB?= X-IronPort-AV: E=Sophos;i="5.77,326,1596513600"; d="scan'208";a="45487454" Received: from unknown (HELO FDSWV30900.fda.gov) ([10.185.43.40]) by ironport7.fda.gov with ESMTP/TLS/ECDHE-RSA-AES256-SHA384; 01 Oct 2020 23:08:07 -0400 Received: from FDSWV09481.fda.gov (10.168.16.140) by FDSWV30900.fda.gov (10.185.43.40) with Microsoft SMTP Server (version=TLS1_2, cipher=TLS_ECDHE_RSA_WITH_AES_256_CBC_SHA384_P256) id 15.1.2044.4; Thu, 1 Oct 2020 23:08:06 -0400 Received: from fdsup05103.fda.gov (10.169.17.4) by FDSWV09481.fda.gov (10.168.17.133) with Microsoft SMTP Server id 15.1.2044.4 via Frontend Transport; Thu, 1 Oct 2020 23:08:06 -0400 Received: from fdslv08717.fda.gov (fdslv08717.fda.gov [10.169.146.87]) by fdsup05103.fda.gov (8.15.1+Sun/8.14.4) with ESMTP id 092383PU000732 for <brodriguez@ifprc.com.pe>; Thu, 1 Oct 2020 23:08:06 -0400 (EDT) Date: Thu, 1 Oct 2020 23:08:03 -0400 From: <fis@fda.gov> To: <brodriguez@ifprc.com.pe> Message-ID: <2055284142.72670.1601608083789@fdslv08717.fda.gov> Subject: FDA Food Facility Registration: 2020 Biennial Renewal Notification (R14215604562R,C428C) MIME-Version: 1.0 Content-Type: text/html; charset="UTF-8" Content-Transfer-Encoding: quoted-printable X-Spam-Status: No, score=1.1 X-Spam-Score: 11 X-Spam-Bar: + X-Ham-Report: Spam detection software, running on the system "pyme91.pymedns.net", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: October 1, 2020 Dear Responsible Official: Your food facility registration is due for renewal. The 2020 Biennial Registration Renewal Period begins October 1, 2020 and concludes on December 31, 2020. Content analysis details: (1.1 points, 5.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4839] 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: fdadunslookup.com] -0.0 SPF_PASS SPF: sender matches SPF record -0.0 SPF_HELO_PASS SPF: HELO matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.1 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain -0.1 DKIM_VALID_EF Message has a valid DKIM or DK signature from envelope-from domain -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature -0.0 FROM_GOV_DKIM_AU From Government address and DKIM signed 0.0 KAM_SHORT Use of a URL Shortener for very short URL 0.4 HTML_MIME_NO_HTML_TAG HTML-only message, but there is no HTML tag X-Spam-Flag: NO <p style=3D"BACKGROUND: white"><span lang=3D"en" style=3D"FONT-SIZE: 11pt; = COLOR: black; mso-ansi-language: EN">October 1, 2020</span></p> <p style=3D= "BACKGROUND: white"><span lang=3D"en" style=3D"FONT-SIZE: 11pt; COLOR: blac= k; mso-ansi-language: EN">Dear Responsible Official:</span></p> <p style=3D= "BACKGROUND: white"><span lang=3D"en" style=3D"FONT-SIZE: 11pt; COLOR: blac= k; mso-ansi-language: EN">Your food facility registration is due for renewa= l. The 2020 Biennial Registration Renewal Period begins October 1, 2020 and= concludes on December 31, 2020.</span></p> <p style=3D"BACKGROUND: white">= <span style=3D"FONT-SIZE: 11pt; COLOR: black">Section 415 of the Federal Fo= od, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 350d] requires food fa= cilities required to register with FDA to renew such registrations during t= he period beginning on October 1 and ending on December 31 of each even-num= bered year</span><span lang=3D"en" style=3D"FONT-SIZE: 11pt; COLOR: black; = mso-ansi-language: EN">. </span></p> <p style=3D"BACKGROUND: white; MARGIN-= LEFT: 0.5in; TEXT-INDENT: -0.25in; mso-list: l0 level1 lfo1"><span style=3D= "FONT-SIZE: 11pt; FONT-FAMILY: Symbol; COLOR: black; mso-fareast-font-famil= y: Symbol; mso-bidi-font-family: Symbol"><span style=3D"mso-list: Ignore">= =B7<span style=3D"FONT: 7pt "Times New Roman""> &nbs= p; </span></span></span><span style=3D"FONT-SIZE: 11pt; C= OLOR: black">If you register your food facility before October 1, 2020, you= must renew your registration before December 31, 2020 and provide us with = any updated information, if applicable. <p></p></span></p> <p style=3D"BACK= GROUND: white; MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; mso-list: l0 level= 1 lfo1"><span style=3D"FONT-SIZE: 11pt; FONT-FAMILY: Symbol; COLOR: black; = mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol"><span style= =3D"mso-list: Ignore">=B7<span style=3D"FONT: 7pt "Times New Roman""> = </span></span></span><span style= =3D"FONT-SIZE: 11pt; COLOR: black">If you updated your food facility regist= ration before October 1, 2020, you must renew your registration before Dece= mber 31, 2020 and provide us with any updated information, if applicable. <= p></p></span></p> <p style=3D"BACKGROUND: white; MARGIN-LEFT: 0.5in; TEXT-I= NDENT: -0.25in; mso-list: l0 level1 lfo1"><span style=3D"FONT-SIZE: 11pt; F= ONT-FAMILY: Symbol; COLOR: black; mso-fareast-font-family: Symbol; mso-bidi= -font-family: Symbol"><span style=3D"mso-list: Ignore">=B7<span style=3D"FO= NT: 7pt "Times New Roman""> = </span></span></span><span style=3D"FONT-SIZE: 11pt; COLOR: black">As a re= minder, if you are the new owner of a registered food facility, the previou= s owner is required to cancel the food facility’s registration within= 60 calendar days of the change of ownership and you must </span><span styl= e=3D"COLOR: black">re</span><span style=3D"FONT-SIZE: 11pt; COLOR: black">-= register the facility reflecting the new ownership (see 21 CFR 1.234 and 1.= 235). <p></p></span></p> <p style=3D"BACKGROUND: white; MARGIN-LEFT: 0.5in;= TEXT-INDENT: -0.25in; mso-list: l0 level1 lfo1"><span style=3D"FONT-SIZE: = 11pt; FONT-FAMILY: Symbol; COLOR: black; mso-fareast-font-family: Symbol; m= so-bidi-font-family: Symbol"><span style=3D"mso-list: Ignore">=B7<span styl= e=3D"FONT: 7pt "Times New Roman"">  = ; </span></span></span><span style=3D"FONT-SIZE: 11pt; COLOR: black">= There is no fee associated with registration or renewal.</span></p> <p styl= e=3D"BACKGROUND: white"><span style=3D"COLOR: black">The owner, operator, o= r agent in charge of the facility, or a person authorized by one of them, c= an submit a facility's registration renewal electronically at </span><= a name=3D"_Hlk52357565"></a><a href=3D"http://www.access.fda.gov/"><span st= yle=3D"mso-bookmark: _Hlk52357565"><b><font color=3D"#0000cc">http://www.ac= cess.fda.gov/</font></b></span></a><span style=3D"mso-bookmark: _Hlk5235756= 5"></span><span lang=3D"en" style=3D"COLOR: black; mso-ansi-language: EN">.= </span><span lang=3D"en" style=3D"COLOR: black"> </span><span style=3D"COLO= R: black">Please note that you must first create or have an existing FURLS = account to access the module and submit your renewal.</span></p> <p style= =3D"BACKGROUND: white"><b style=3D"mso-bidi-font-weight: normal"><span styl= e=3D"COLOR: black">In accordance with 21 CFR 1.232(a)(2), effective October= 1, 2020, all facilities must include a unique facility identifier (UFI) re= cognized as acceptable by FDA with their registration information. To date,= FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number a= s an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bra= dstreet and is available free of charge. Please visit the FDA DUNS Portal a= t <a href=3D"https://fdadunslookup.com/"><span style=3D"FONT-WEIGHT: normal= ; mso-bidi-font-weight: bold"><font color=3D"#0000cc">https://fdadunslookup= .com/</font></span></a> in order to obtain or verify your DUNS number. You = will be required to provide your UFI in “Section 2- Facility Name/Add= ress Information” of your registration.</span></b><b style=3D"mso-bid= i-font-weight: normal"><span style=3D"FONT-SIZE: 11pt; COLOR: black"> <p></= p></span></b></p> <p style=3D"BACKGROUND: white"><span style=3D"COLOR: blac= k">Please visit </span><a href=3D"http://www.fda.gov/Food/GuidanceRegulatio= n/FoodFacilityRegistration/default.htm"><b><font color=3D"#0000cc">http://w= ww.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm</fo= nt></b></a><span style=3D"COLOR: black"> for more information about food fa= cility registration and the 20</span><span style=3D"FONT-SIZE: 11pt; COLOR:= black">20</span><span style=3D"COLOR: black"> biennial renewal including g= uidance documents and user guides for our Food Facility Registration Module= (FFRM).</span><span style=3D"FONT-SIZE: 11pt; COLOR: black"> <span style= =3D"mso-spacerun: yes"> </span> <p></p></span></p> <p style=3D"BACKGRO= UND: white"><span style=3D"FONT-SIZE: 11pt; COLOR: black">Also, if you have= submitted a qualified facility attestation before October 1, 2020, you mus= t re-submit your attestation before December 31, 2020(21 CFR 117.205(c)(2)(= ii)). Please re-submit your attestation electronically via the Qualified Fa= cility Attestation Module also at <a href=3D"http://www.access.fda.gov/"><b= ><font color=3D"#0000cc">http://www.access.fda.gov/</font></b></a>. Please = ensure that your registration is renewed before re-submitting your qualifie= d facility attestation.</span><span style=3D"FONT-SIZE: 11pt; COLOR: black"= > <p> </p></span></p> <p><span style=3D"FONT-SIZE: 11pt; COLOR: black"= >Please remember that this renewal process repeats every two years on even-= numbered years from October 1 through December 31. You may wish to set a re= minder. </span></p><span style=3D"FONT-SIZE: 11pt; FONT-FAMILY: "Times New = Roman",serif; COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-US; ms= o-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-fa= reast-language: EN-US; mso-bidi-language: AR-SA">Please contact the FDA Ind= ustry Systems Help Desk at </span><span style=3D"FONT-SIZE: 12pt; FONT-FAMI= LY: "Times New Roman",serif; LINE-HEIGHT: 115%; mso-ansi-language: EN-US; m= so-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-f= areast-language: EN-US; mso-bidi-language: AR-SA"><a><b><span style=3D"FONT= -SIZE: 11pt; LINE-HEIGHT: 115%">furls@fda.gov</span></b></a></span><span st= yle=3D"FONT-SIZE: 11pt; FONT-FAMILY: "Times New Roman",serif; COLOR: black;= LINE-HEIGHT: 115%; mso-ansi-language: EN-US; mso-fareast-font-family: Cali= bri; mso-fareast-theme-font: minor-latin; mso-fareast-language: EN-US; mso-= bidi-language: AR-SA">, toll-free in the USA 1-800-216-7331, or 240-247-880= 4 if you require additional assistance</span><span style=3D"FONT-SIZE: 11pt= ; FONT-FAMILY: "Calibri",sans-serif; COLOR: black; LINE-HEIGHT: 115%; mso-a= nsi-language: EN-US; mso-ascii-theme-font: minor-latin; mso-fareast-font-fa= mily: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: m= inor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: m= inor-bidi; mso-fareast-language: EN-US; mso-bidi-language: AR-SA">. When co= ntacting the FDA by phone, please anticipate long hold times during the ren= ewal period. Likewise, please anticipate a delay in the time it takes FDA t= o respond to e-mails due to the significant increase in call and email volu= me that FDA receives during the registration renewal period.</span>