tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Fair Fish Co., Inc.
MARCS-CMS 555019 —
December 20, 2018
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Frank D. Fogliano
Recipient Title
President
Fair Fish Co., Inc.
800 Food Center Dr. Unit #21
Bronx
,
NY
10474-0015
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Fogliano:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 555019, issued on May 31, 2018. 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 future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
02/27/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Fallon Wellness Pharmacy, L.L.C.
MARCS-CMS 485889 —
December 18, 2018
Delivery Method:
UPS NEXT DAY DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Peter L. Fallon
Recipient Title
Owner
Fallon Wellness Pharmacy, L.L.C.
1057 Troy-Schenectady Road
Latham
,
NY
12110-1002
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Fallon:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter, WL # NYK-2016-23, dated February 1, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 assure 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/
Diana Amador-Toro
Program Division Director
OPQO Division 1
New Jersey District Office
Content current as of:
02/04/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Finemost Corporation
February 15, 2018
Recipient:
Finemost Corporation
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild, Irvine CA
Telephone: 949-608-2900
Fax: 949-608-4417
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
February 15, 2018
Mr. Samuel S. Chang, CEO
Finemost Corporation
13839 Bentley Place
Cerritos, CA 90703
Dear Mr. Chang:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [WL#32-13 issued March 20, 2013]. 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 future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Darla Bracy, District Director
Office of Human and Animal Food
Division 5 West
Content current as of:
03/20/2018
CLOSEOUT LETTER
FireVapor.com
MARCS-CMS 563335 —
November 14, 2018
Delivery Method:
Electronic Mail
Reference #:
1800961
Product:
Tobacco
Recipient:
Recipient Name
Jason Ogden
FireVapor.com
United States
ceo@firevapor.com
inquiry@firevapor.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Jason Ogden:
On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your V'Nilla Cookies and Milk e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading. Specifically, FDA determined that the labeling and/or advertising of your V'Nilla Cookies & Milke-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On September 12, 2018, October 22, 2018, and November 8, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on October 22, 2018, and November 8, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
Registration Private
Domains By Proxy, LLC
firevapor.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify Inc.
abuse@shopify.com
Content current as of:
04/05/2019
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Flying Food Group, LLC.
MARCS-CMS 469636 —
February 02, 2018
Recipient:
Flying Food Group, LLC.
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild, Irvine CA
Telephone:
949-608-2900
Fax:
949-608-4417
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
March 2, 2018
Ms. Ieta M. Maiava, General Manager
Flying Food Group, LLC.
3305 Bandini Boulevard
Vernon, CA 90058
RE: WL #14-16 Close-Out Letter
Dear Ms. Maiava:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [WL # 14-16 issued December 22, 2015]. 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 future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Darla Bracy, District Director
Office of Human and Animal Food
Division 5 West
cc: Mr. David Cotton, President and CEO
Flying Food Group, LLC.
212 N. Sangamon Street
Chicago, IL 60607
Content current as of:
03/28/2018
CLOSEOUT LETTER
Fog It Up
MARCS-CMS 553051 —
July 13, 2018
Recipient:
Fog It Up
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 13, 2018
VIA USPS and Electronic Mail
Fog It Up
P.O Box 9418
Fountain Valley, CA 92728
admin@fogitup.com
RE: Warning Letter issued to Fog It Up (RW1800857)
Dear Fog It Up:
On May 1, 2018, the United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your V’Nilla Cookies & Milk e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading
.
The Warning Letter also informed you that this product ismisbranded under section 903(a)(7)(B) because you sold itto a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(b)(1). Specifically, FDA determined that the labeling and/or advertising of your V’Nilla Cookies & Milk e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children. FDA also determined that a person younger than 18 years of age was able to purchase V’Nilla Cookies & Milk e-liquid from your website.
Based on our evaluation, it appears that you have taken steps to address the violations identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Domains By Proxy, LLC
FOGITUP.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Formulife, Inc.
MARCS-CMS 508605 —
March 02, 2018
Recipient:
Formulife, Inc.
United States
Issuing Office:
United States
Office of Human &Animal Food Operations, West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204
March 2, 2018
UPS Overnight
Brandon M. Smith, Owner and President
Formulife, Inc.
Purus Labs, Inc.
1253 Andrews Parkway
Allen, Texas 75002-2692
Dear Mr. Smith:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letters (2012-DAL-WL-12, January 18, 2012; 2013-DAL-WL-38, June 17, 2013; and 2017-DAL-WL-21, May 12, 2017). Based on our evaluation, it appears that you have addressed the violations contained in these Warning Letters. 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/
Chad J. Whitwell
Acting Director, Compliance Branch
Human & Animal Food Operations, WD3
Content current as of:
03/05/2018
CLOSEOUT LETTER
Gate Gourmet Inc.
MARCS-CMS 543440 —
May 14, 2018
Recipient:
Gate Gourmet Inc.
United States
Issuing Office:
United States
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone:
(513) 679-2700
FAX:
(513) 679-2772
May 14, 2018
Dawn M. Sanchez, General Manager
Gate Gourmet, Inc.
3298 Lincoln Road Unit 117
Erlanger, Kentucky 41018
Dear Ms. Sanchez:
The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 543440, where a "Provisional" status was given to your firm. Based on our re-inspection of your facility on April 24 and 26, 2018, it appears you have addressed the violations contained in this warning letter. Therefore, the classification is being changed to "Approved."
We acknowledge your response dated April 11, 2018, addressing corrective actions to the violations cited on the Form FDA 483, issued to you on April 26, 2018. Your corrective actions to the cited violations appear adequate. 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/
Kimberly A. Dutzek
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
06/25/2018
CLOSEOUT LETTER
Genetic Edge Compounds
MARCS-CMS 510403 —
June 05, 2018
Recipient:
Genetic Edge Compounds
United States
Issuing Office:
United States
Office of Human and Animal Food Operations West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204
May 29, 2018
UPS OVERNIGHT
Bradley N. Howard, Owner and CEO
Genetic Edge Compounds, LLC
(b)(6), (b)(7)(C)
McKinney, Texas 75070
Mr. Howard:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-15, dated April 14, 2017. 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/
Jessica E. Hensley
Director, Compliance Branch
Office of Human and Animal Foods, West - Division 3
Content current as of:
06/11/2018
CLOSEOUT LETTER
Gialive SA de CV
MARCS-CMS 470118 —
November 27, 2018
Reference #:
Re:470118
Recipient:
Recipient Name
Edgar Arroyo Gonzalez
Recipient Title
General Director and Legal Representative
Gialive SA de CV
Gialive SA de CV
Carretera a Zacatecas km # 8
Col. TALAMANTES PONCE
20311
Aguascalientes
,
Ags.
Mexico
Issuing Office:
United States
Dear Mr. Edgar Arroyo Gonzalez:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 470118, dated August 28, 2015. 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/
Carrie A. Lawlor
Branch Chief
Center for Food Safety and Applied Nutrition
Office of Compliance/ Division of Enforcement/Dietary
Supplement and Labeling Assessment Branch
Content current as of:
11/30/2018
CLOSEOUT LETTER
Gilchrist & Soames
MARCS-CMS 485833 —
February 20, 2018
Recipient:
Gilchrist & Soames
United States
Issuing Office:
United States
Chicago District Office
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Telephone:
(312) 353-5863
Fax:
(312) 596-4187
February 20, 2018
VIA UPS
Paul Xenis, COO and President
Sysco Guest Supply, LLC
300 Davidson Ave.
Somerset, NJ 08873
Dear Mr. Xenis,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2016-DET-09, dated March 16, 2016. 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 future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Operations
Division East 6
CC:
Donald Turgeon, General Manager and CFO
Gilchrist & Soames
2425 E. Perry Rd
Suite 150
Plainfield, IN 46168
Content current as of:
02/22/2018
CLOSEOUT LETTER
GliSODin Skin Nutrients
MARCS-CMS 552094 —
September 11, 2018
Recipient:
GliSODin Skin Nutrients
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
September 11, 2018
Corina Crysler, Co-Founder
GliSODin Skin Nutrients
503-639 Queen St. W.
Toronto, Ontario M5V 2B7
Canada
Dear Ms. Crysler:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #552094, issued May 18, 2018. 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:
09/14/2018
CLOSEOUT LETTER
God Quest, Inc. d/b/a Creation Today
MARCS-CMS 522709 —
March 05, 2018
Recipient:
God Quest, Inc. d/b/a Creation Today
United States
Issuing Office:
United States
Office of Regulatory Affairs
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel:
(787) 729-8500
Office of Regulatory Affairs
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel:
(787) 729-8500
March 5, 2018
18-HAFE4-WLCOL-03
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Mr. Eric M. Hovind, President
God Quest, Inc. d/b/a Creation Today
29 Cummings Road
Pensacola, FL 32503
Re: Warning Letter, 17-OHAFOED4-WL-06/CMS No.522709 dated 06/29/2017
Dear Mr. Hovind:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, 17-OHAFOED4-WL-06/CMS No.522709 dated 06/29/2017. 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 future regulatory action should violations be observed during a subsequent inspection or through other means.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO East Division IV
Content current as of:
03/07/2018
CLOSEOUT LETTER
Golden Caviar Skin Care
MARCS-CMS 456827 —
June 27, 2018
Recipient:
Golden Caviar Skin Care
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 27, 2018
Pooneh Manshadi
Golden Caviar Skin Care
18732 Via Verona
Irvine, CA 92603-3441
Dear Ms. Manshadi:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #456827, issued July 13, 2015. 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
Acting Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Content current as of:
07/06/2018