tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Saffron Health Sciences
MARCS-CMS 615429 —
January 18, 2022
Delivery Method:
Next Day Air
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Song Gao
Saffron Health Sciences
13 Dexter Rd
E Brunswick
,
NJ
08816-2873
United States
natureway62@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Dr. Gao;
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS #615429, dated November 18, 2021. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any further regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Andrew Howard
Consumer Safety Officer/Compliance Officer
Office of Human and Animal Food East II
Baltimore District Office
U.S. Food and Drug Administration
Tel: 410-779-5125
Andrew.Howard@fda.hhs.gov
Content current as of:
02/15/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Sarita's Tortilla Factory, Inc
MARCS-CMS 617384 —
November 30, 2022
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Maria X. Villarreal
Recipient Title
CEO and Co-Owner
Sarita's Tortilla Factory, Inc
2505 El Indio Hwy
Eagle Pass
,
TX
78852-5537
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 3
United States
Dear Ms. Villarreal,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated November 22, 2021, issued following inspection of your facility located at 2505 El Indio Hwy., Eagle Pass, TX 78852-5537. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations, or with other relevant legal authority. If you choose to reestablish or sell your operations, the Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
René R. Ramirez
Compliance Officer
Office of Human and Animal Foods, West Division 3
Content current as of:
12/07/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
SAS Technologies, Inc d/b/a Save A Smoker
MARCS-CMS 625483 —
June 16, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201727
Product:
Tobacco
Recipient:
Recipient Name
Eric Slaick
SAS Technologies, Inc d/b/a Save A Smoker
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Eric Slaick:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated February 9, 2022 and June 9, 2022 in response to our Warning Letter dated January 21, 2022. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.saveasmoker.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Domains By Proxy, LLC
saveasmoker.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
06/24/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Sema International Inc.
MARCS-CMS 614691 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101594
Product:
Tobacco
Recipient:
Recipient Name
Anan Barbarawi
Sema International Inc.
United States
sema.international@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Anan Barbarawi:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated May 17, 2021 in response to our Warning Letter dated May 7, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://semavape.com.
However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
1&1 IONOS SE
abuse@ionos.com
1&1 IONOS Inc.
abuse@1and1.com
Content current as of:
06/07/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Shopaax.com
MARCS-CMS 626291 —
September 02, 2022
Product:
Dietary Supplements
Recipient:
Recipient Name
Lahoucine Mousstaid
Shopaax.com
2 Burleigh Ct., Apartment A5
Newark
,
DE
19702
United States
support@shopaax.com
aleemadibrahim@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Mr. Bhatia,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #626291, issued July 1, 2022. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/13/2026
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Signa S.A. de C.V.
MARCS-CMS 605219 —
July 07, 2022
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Mr. Jeff Watson
Recipient Title
President & Chief Executive Officer
Signa S.A. de C.V.
Apotex Inc.
150 Signet Drive
Toronto
ON
M9L 1T9
Canada
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Watson:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-40 dated July 14, 2020.
Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.
The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Chhaya Shetty
Compliance Officer
Division of Drug Quality I
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
07/15/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Stanley Specialty Pharmacy Compounding and Wellness Center
MARCS-CMS 557711 —
February 08, 2022
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Douglas Yoch
Recipient Title
Pharmacist-In-Charge
Stanley Specialty Pharmacy Compounding and Wellness Center
3120 Latrobe Dr.
Ste. 200
Charlotte
,
NC
28211-2185
United States
Issuing Office:
Drug Product/Adulterated
United States
Mr. Yoch:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case # 557711; dated July 24, 2018]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
U.S.
Content current as of:
02/08/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sunny Creek Farm Inc.
MARCS-CMS 617664 —
December 08, 2022
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Lee G. Ewing
Recipient Title
President and Owner
Sunny Creek Farm Inc.
520 Pinefield Drive
Tryon
,
NC
28782-7795
United States
Lee.Ewing@sunnycreekfarm.com
Issuing Office:
Division of Human and Animal Food Operations East III
United States
Dear Mr. Ewing:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter 617664 dated February 2, 2022. We also verified your actions during an FDA inspection that ended September 15, 2022. Based on our evaluation and inspection, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
For questions about this letter, please contact: Stephen J. Rabe, Compliance Officer at: orahafeast3firmresponses@fda.hhs.gov and Stephen.rabe@fda.hhs.gov or by telephone at: 513-322-0660:
Sincerely,
/S/
Stephen J. Rabe
Compliance Officer
Content current as of:
12/12/2022
Regulated Product(s)
Food & Beverages
RESPONSE LETTER
Synaptent, LLC
February 01, 2022
Reference #:
FY22-HAFE-WL-01
Company:
Synaptent, LLC
Synaptent, LLC
1442 W. Fulton St.
Chicago
,
IL
60607
United States
18886796278
Recipient:
Lauren Crivellone
Compliance Officer
United States
Attention: Lauren Crivellone
Compliance Officer, U.S. Food and Drug Administration
Office of Human and Animal Food Operations – Div. East 6
550 W. Jackson Blvd Suite 1500
Chicago, IL 60661
Phone: (312) 596-4157
Re: Synaptent LLC (FEI 27-2205416) Warning Letter (FY22-HAFE6-WL-01) Response
Ms. Crivellone:
The Warning Letter was received on November 9th, 2021. This response is timely.
Synaptent LLC appreciates your bringing problematic claims on our www.liftmode.com website to our attention. Our firm is committed to full compliance with applicable regulations, and we shall remove or revise all the statements or claims identified in the warning letter that might be perceived to establish our firm’s products as “drugs” under 201(g)(1) of the Act [21 U.S.C. §321(g)(1)], “unapproved drugs” ” under section 201(p) of the Act [21 U.S.C. § 321(p)], or “misbranded drugs” under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. Corrections to the content on our site are ongoing and will be completed within the next 5 business days.
We believe the corrective actions we are taking to revise the content on our site should substantially satisfy the Agency's concerns about such claims. We further commit to ongoing review of existing and new claims and site content with legal counsel specializing in FDA compliance, and we anticipate ongoing regular review will mitigate risk of further reoccurrence. Upon initial review, a few potentially problematic phrases and images on our site beyond those mentioned in the Warning Letter have been identified and are also being revised or removed.
Synaptent LLC also acknowledges the failure of some of our product labeling to express product weight in terms of avoirdupois pound and ounce units as required by 21 CFR 101.7(b)(1) which may cause our supplement products to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]. We are revising all deficient product labeling to include product weights in the required measurement units within 10 business days and will ensure all respective product images and finished goods available for purchase reflect the corrected labels within 60 business days.
Pursuant to the Regulatory Procedures Manual § 4-1-8(2), we respectfully request this response be posted on the Agency's website, redacted as deemed necessary.
Kind Regards,
Armand Tuzel
Managing Member
Synaptent LLC
Content current as of:
02/15/2022
Regulated Product(s)
Drugs
RESPONSE LETTER
Synaptent, LLC
February 01, 2022
Company:
Synaptent, LLC
1442 W. Fulton St
Chicago
,
IL
60607
United States
https://synaptent.com
Recipient:
Lauren Crivellone
Compliance Officer
United States
Re: Synaptent LLC (FEI 27-2205416) Warning Letter (FY22-HAFE6-WL-01) Response
Ms. Crivellone:
The Warning Letter was received on November 9th, 2021. This response is timely.
Synaptent LLC appreciates your bringing problematic claims on our www.liftmode.com website to our attention. Our firm is committed to full compliance with applicable regulations, and we shall remove or revise all the statements or claims identified in the warning letter that might be perceived to establish our firm’s products as “drugs” under 201(g)(1) of the Act [21 U.S.C. §321(g)(1)], “unapproved drugs” ” under section 201(p) of the Act [21 U.S.C. § 321(p)], or “misbranded drugs” under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. Corrections to the content on our site are ongoing and will be completed within the next 5 business days.
We believe the corrective actions we are taking to revise the content on our site should substantially satisfy the Agency's concerns about such claims. We further commit to ongoing review of existing and new claims and site content with legal counsel specializing in FDA compliance, and we anticipate ongoing regular review will mitigate risk of further reoccurrence. Upon initial review, a few potentially problematic phrases and images on our site beyond those mentioned in the Warning Letter have been identified and are also being revised or removed.
Synaptent LLC also acknowledges the failure of some of our product labeling to express product weight in terms of avoirdupois pound and ounce units as required by 21 CFR 101.7(b)(1) which may cause our supplement products to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]. We are revising all deficient product labeling to include product weights in the required measurement units within 10 business days and will ensure all respective product images and finished goods available for purchase reflect the corrected labels within 60 business days.
Pursuant to the Regulatory Procedures Manual § 4-1-8(2), we respectfully request this response be posted on the Agency's website, redacted as deemed necessary.
Kind Regards,
/S/
Armand Tuzel
Managing Member
Synaptent LLC
Content current as of:
02/01/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Tec Laboratories, Inc.
MARCS-CMS 568666 —
July 29, 2022
Delivery Method:
Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Steven D. Smith
Recipient Title
President and CEO
Tec Laboratories, Inc.
7100 Tec Labs Way, SW
Albany
,
OR
97321
United States
steve@teclabsinc.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. Smith:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter dated March 20, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
08/17/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Thai Union Group PLC
MARCS-CMS 630100 —
September 08, 2022
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Wachira Katueang-Ngan
Recipient Title
Quality Manager
Thai Union Group PLC
72/1 Moo 7 Sethakit 1 Road
Tambon Tarsrai
Amphoe Mueang
Samut Sakhon
74000
Thailand
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear: Ms. Wachira Katueang-Ngan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 630100, issued April 20, 2022. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
We note, you’re implementing your HACCP plan Frozen Precooked Tuna Loin for USA as written, however the monitoring frequency identified in the plan for the cooking temperature is inadequate. Please ensure the monitoring frequency is in compliance with 21 CFR 123.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/18/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Torrent Pharma Inc
MARCS-CMS 584701 —
March 11, 2022
Delivery Method:
Return Receipt Requested
Product:
Drugs
Recipient:
Recipient Name
Mr. Sanjay Gupta
Recipient Title
President and CEO
Torrent Pharma Inc
2091 Hartel Ave.
Levittown
,
PA
19057
United States
sanjayqupta@torrentpharma.us
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Dear Mr. Gupta:
The Food and Drug Administration has completed evaluation of Torrent Pharma, Inc. corrective actions in response to our Warning Letter [WL #584701, dated October 28, 2019]. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Craig Swanson
Acting Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I
Content current as of:
03/18/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Toxikon Corporation/Labcorp Bedford LLC
MARCS-CMS 623581 —
October 25, 2022
Product:
Biologics
Recipient:
Recipient Name
Matthew Renninger, DVM, PhD
Recipient Title
Vice President
Toxikon Corporation/Labcorp Bedford LLC
Toxikon Corporation
15 Wiggins Avenue
Bedford
,
MA
01730-2314
United States
Issuing Office:
Center for Biologics Evaluation and Research
United States
Dear Dr. Renninger:
The United States Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CBER-22-001 dated February 10, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or other applicable law.
Sincerely,
/S/
Melissa J. Mendoza, JD
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
cc: Anne E. Johnson, Director
FDA ORA-BIMO East
Content current as of:
11/02/2022
Regulated Product(s)
Biologics