tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Taiyo Seafood New York, Inc.
MARCS-CMS 435696 —
December 06, 2018
Recipient:
Recipient Name
Shou Xi Li
Recipient Title
President
Taiyo Seafood New York, Inc.
Taiyo Seafood New York, Inc.
38 Locust Street
Brooklyn
,
NY
11206-4512
United States
Issuing Office:
Public Health Service
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Li:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2014-51 dated July 30, 2014. 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/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1
Content current as of:
12/10/2018
CLOSEOUT LETTER
TaperAid
MARCS-CMS 542770 —
September 18, 2018
Recipient:
Recipient Name
Richie Ogulnick
TaperAid
TaperAid
2405 NW 31st Terrace
Gainesville
,
FL
32605-2730
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Ogulnick:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 542770, issued January 11, 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 Supplements and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/01/2018
CLOSEOUT LETTER
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.
MARCS-CMS 516381 —
April 25, 2018
Recipient:
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
April 25, 2018
Daniel (NMI) Chemouny
General Manager
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.
No. 1889 Jingliu Road, Linjiang Industrial Zone
Hangzhou, Zhejiang, 311228 P.R.C.
Reference: FEI 3009271645
Dear Mr. Chemouny:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-17-33 dated April 5, 2017. 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/
Rebecca Parrilla
Compliance Officer
Division of Drug Quality I
Content current as of:
04/26/2018
CLOSEOUT LETTER
Texas Plum Line
MARCS-CMS 534263 —
May 03, 2018
Recipient:
Texas Plum Line
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 3, 2018
UPS OVERNIGHT
Connie J. Bingham, Owner
Texas Plum Line
5060 Helium Road
Amarillo, Texas 79124
Dear Ms. Bingham
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-29 dated September 22, 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 sale 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 of Compliance Branch, OHAF-W3
Content current as of:
05/07/2018
CLOSEOUT LETTER
Tinted Brew, Inc
MARCS-CMS 553052 —
July 31, 2018
Recipient:
Tinted Brew, Inc
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 31, 2018
VIA UPS and Electronic Mail
Jonathan Nemr
Tinted Brew, Inc.
21416 Chase St.,Ste 1
Canoga Park, CA 91304-2547
info@tintedbrew.com
jon@tintedbrew.com
RE: Warning Letter issued to Tinted Brew Inc.(RW1800856)
Dear Jonathan Nemr:
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. 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.
On May 22, 2018, June 7, 2018, July 2, 2018, and July 10, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on June 7, 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.
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 UPS and Electronic Mail
cc:
Areta Kupchyk
Foley Hoag LLP
1717 K Street NW
Washington, DC 20006
akupchyk@foleyhoag.com
Domains By Proxy, LLC
TINTEDBREW.COM@domainsbyproxy.com
GoDaddy.com
abuse@godaddy.com
Shopify Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Total Nutrition Inc
MARCS-CMS 525508 —
July 24, 2018
Recipient:
Total Nutrition Inc
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
July 24, 2018
Mr. Jay M. Silverman, President
Total Nutrition, Inc.
75 Bi-County Boulevard
Farmingdale, NY 11735
Dear Mr. Silverman:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 525508, issued on August 16, 2017. 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:
08/14/2018
CLOSEOUT LETTER
Trapper's Creek Inc. DBA Copper River Smoking Co
July 24, 2018
Recipient:
Trapper's Creek Inc. DBA Copper River Smoking Co
United States
Issuing Office:
United States
Seattle District Office
22215 25th Avenue SE, Suite 210
Bothell, Washington 98021
July 24, 2018
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
Andrea Wahry, President
Trapper's Creek, Inc.
dba Copper River Smoking Company
240 15th Street SE #A
Puyallup, Washington 98372
Dear Ms. Wahry:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 17-06, dated February 28, 2017. 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/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
07/30/2018
CLOSEOUT LETTER
Tri-Med, Inc. dba Advanced Care Infusion-Shelby
MARCS-CMS 478092 —
May 02, 2018
Recipient:
Tri-Med, Inc. dba Advanced Care Infusion-Shelby
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI 48207
Telephone:
(313) 393-8100
Fax:
(313) 393-8139
May 2, 2018
UPS NEXT DAY
SIGNATURE REQUIRED
Dr. William C. Drake, PharmD
President
Tri-Med, Inc. dba Advanced Care Infusion-Shelby
39011 Harper Avenue
Clinton Township, MI 48036
Dear Dr. Drake:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter 2016-DET-04 dated December 18, 2015. 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/
Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III
Content current as of:
05/07/2018
CLOSEOUT LETTER
Tribravus Enterprises, LLC
MARCS-CMS 456725 —
June 27, 2018
Recipient:
Tribravus Enterprises, LLC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 27, 2018
Mr. David Nelson
Tribravus Enterprises, LLC dba iForce Nutrition
1305 Hot Spring Way #103
Vista, CA 92081
1330 Specialty Drive, Suite A
Vista, CA 92081
Dear Mr. Nelson:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 456725, issued April 22, 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 Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/23/2018
CLOSEOUT LETTER
Tropic Fish Hawaii, LLC
MARCS-CMS 501652 —
March 30, 2018
Recipient:
Tropic Fish Hawaii, LLC
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone:
510-337-6700
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
March 30, 2018
Mr. Shawn Tanoue, President
Tropic Fish Hawaii, LLC
2312 Kamehameha Hwy, Unit E-5
Honolulu, HI 96819
RE: WL #501652 Close-Out Letter
Dear Mr. Tanoue:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter WL#501652 dated July 27, 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/
Director Compliance Branch
Office of Human and Animal Food
Division 5 West
Content current as of:
04/11/2018
CLOSEOUT LETTER
Ultimate Vape Deals
MARCS-CMS 553198 —
July 13, 2018
Recipient:
Ultimate Vape Deals
United States
Issuing Office:
United States
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
VIA UPS and Electronic Mail
Ultimate Vape Deals
7600 Chevy Chase Drive
Building 2, Suite 300
Austin, TX 78752
ultimatevapedeals@gmail.com
sales@ultimatevapedeals.com
info@ultimatevapedeals.com
RE: Warning Letter issued to Ultimate Vape Deals (RW1800865)
Dear Ultimate Vape Deals:
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 Vape Heads Sour Smurf Sauce 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 is misbranded under section 903(a)(7)(B) because you sold
it to 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 Vape Heads Sour Smurf Sauce 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 Vape Heads Sour Smurf Sauce e-liquid from your website.
On May 9, 2018, you sent FDA a response to the Warning Letter.  In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter.
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 UPS and Electronic Mail
cc:
Ultimate Vape Deals
1499 Pomona Road
Corona, CA 92882
pw-4d775ac8bddfaf8fd1b67fb84e1dd276@privacyguardian.org
Sean R. Kelley
Kelley Law
1147 Railroad Street
Corona, CA 92882
sean@srkelleylaw.com
NameSilo, LLC
abuse@namesilo.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
United Exchange Corporation
MARCS-CMS 565551 —
November 30, 2018
Recipient:
Recipient Name
Ellen Chang
United Exchange Corporation
United Exchange Corporation
17211 Valley View Ave.
Cerritos
,
CA
90703
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Ellen Chang:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1285, issued on October 29, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and delisted the product by the way of including a marketing end date. Future FDA regulatory activities will further assess the adequacy and sustainability of these actions.
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 to 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/
Maria Rossana R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
12/04/2018
CLOSEOUT LETTER
University Rx Specialists Inc
MARCS-CMS 495985 —
December 11, 2018
Delivery Method:
SIGNATURE CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Joseph Grasela, RPh
Recipient Title
President/Owner
University Rx Specialists Inc
University Compounding Pharmacy
1875 3rd Avenue
San Diego
,
CA
92101-2604
United States
Issuing Office:
Center for Drug Evaluation and Research
19701 Fairchild
Irvine
,
CA
92612-2506
United States
949-608-2900
Dear Mr. Grasela:
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 # 51-16, dated September 28, 2016. We acknowledge that your firm receives valid prescriptions for individually-identified patients for all of the drug products you produce. 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
08/14/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Usv Limited
MARCS-CMS 510159 —
February 14, 2018
Recipient:
Usv Limited
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
February 14, 2018
Mr. Prashant K. Tewari
Managing Director
USV Private Limited
Arvind Yi thal Gandhi Chowk, B.S.D. Marg,
Govandi, Mumbai 400 088
India
Reference: PEI: 3004086 192
Dear Mr. Tewari:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-29 dated March 10, 2017. 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 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 violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Frank Verni, R.Ph., MPH
Compliance Officer
Division of Drug Quality II
Content current as of:
02/15/2018