tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
SK Food Group, Inc.
MARCS-CMS 515676 —
August 13, 2018
Recipient:
SK Food Group, Inc.
United States
Issuing Office:
United States
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
August 13, 2018
Mr. Jakob Loseke,
Vice President for U. S. Operation and Plant Manager
SK Food Group, Inc.
5555 Quail Manor Court, Suite 100
Reno, NV 89511
CMS#515676
Dear Mr. Jakob Loseke:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 515676), dated March 13, 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. 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/
Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5
Content current as of:
09/17/2018
CLOSEOUT LETTER
Smoke and Vape
MARCS-CMS 559902 —
November 08, 2018
Delivery Method:
UPS and Electronic Mail
Reference #:
1800916
Recipient:
Recipient Name
Maher Lababidi
Smoke and Vape
17197 Newhope St. Ste# F
Fountain Valley
,
CA
92708
United States
info@smokeandvape.com
sales@smokeandvape.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Maher Lababidi:
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 Candy King Batch 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 Candy King Batch 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 Candy King Batch e-liquid from your website.
On September 22, 2018 you sent FDA a response to the Warning Letter, and we held a teleconference on October 19, 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 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 violat!ons 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:
NameCheap Inc.
abuse@namecheap.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
04/05/2019
CLOSEOUT LETTER
Snyder's Lance Inc.
MARCS-CMS 536150 —
August 24, 2018
Recipient:
Snyder's Lance Inc.
United States
Issuing Office:
United States
60 Eighth Street N.E.
Atlanta, GA 30309
August 24, 2018
Ron Pepperdine
Director Regulatory Affairs
Snyder’s-Lance, Inc.
13515 Ballantyne Corporate Place
Charlotte, NC 28277
RE: Warning Letter (17-ATL-12)
Dear Mr. Pepperdine,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter [17-ATL-12 dated October 4, 2017]. Based on our evaluation during the March 6-9, 2018 visit to your facility, it appears that you have addressed the violation(s) 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.
If you have any questions regarding this letter, you may contact Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. You may also contact Ms. King at
(843) 746-2990
x16 or via email at
janice.king@fda.hhs.gov
.
Sincerely,
/S/
Derek Price
Compliance Branch Director
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Content current as of:
08/23/2018
CLOSEOUT LETTER
Soothedrawal, Inc.
MARCS-CMS 543430 —
September 11, 2018
Recipient:
Soothedrawal, Inc.
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
September 11, 2018
Soothedrawal, Inc.
Attn: David McDonald
Attn: Terrie McDonald
3330 Cobb Pkwy NW
Suite 324
Acworth, GA 30101
Dear Mr. and Ms. McDonald:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 543430, 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 Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
09/24/2018
CLOSEOUT LETTER
Spoonamore Drug Co Inc
MARCS-CMS 455964 —
May 17, 2018
Recipient:
Spoonamore Drug Co Inc
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 17, 2018
UPS NEXT DAY
SIGNATURE REQUIRED
Steven D. Williams
President and Owner
Spoonamore Drug Company, Inc. dba
Louisville Pharmacy and Custom Script
4014 Dutchmans Lane, Suite 11
Louisville, KY 40207
Dear Mr. Williams:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [CIN-16-455964-04] issued on 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
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
06/05/2018
CLOSEOUT LETTER
St. Jude Medical (CardioMEMS)
MARCS-CMS 480398 —
October 17, 2018
Recipient:
Recipient Name
Mr. Heerain Piplani
Recipient Title
Operations Director
St. Jude Medical (CardioMEMS)
387 Technology Circle NW
Suite 500
Atlanta
,
GA
30313
United States
Issuing Office:
Office of Medical Device and Radiological Health Division 2 - Central
United States
(407) 475-4700
Dear Mr. Piplani:
The Food and Drug Administration has completed an evaluation of your ftrm's corrective actions in response to our Warning Letter [15-ATL-13 dated September 30, 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/
Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central
Content current as of:
11/25/2020
CLOSEOUT LETTER
St. Moritz Bakery Inc
MARCS-CMS 476843 —
May 31, 2018
Recipient:
St. Moritz Bakery Inc
United States
Issuing Office:
United States
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
May 31, 2018
Mr. Manfred H. Maehler, CEO
St. Moritz Bakery Inc. dba Mahler’s Bakery
1943 Avenida Plaza Real
Oceanside, CA 92056
Dear Mr. Manfred H. Maehler:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 476843), dated March 11, 2016. 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/
Sergio Chavez
Director of Compliance
Office Human and Animal Foods
Division West 5
Content current as of:
06/08/2018
CLOSEOUT LETTER
Staar Surgical Co.
MARCS-CMS 423326 —
June 15, 2018
Product:
Medical Devices
Recipient:
Staar Surgical Co.
United States
Issuing Office:
United States
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 15, 2018
Ms. Caren Mason, President and Chief Executive Officer
STAAR Surgical Company
1911 Walker Avenue
Monrovia, CA 91016
Dear Ms. Mason:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #20-14), dated 05/21/2014. 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/
Kelly D. Sheppard
Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations
Content current as of:
06/21/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Stat Medical Devices, Inc.
MARCS-CMS 473754 —
March 28, 2018
Recipient:
Stat Medical Devices, Inc.
United States
Issuing Office:
United States
555 Winderley Place #200
Maitland, FL 32751
Telephone:
(407) 475-4700
VIA ELECTRONIC MAIL
sschraga@statdevices.com
March 28, 2018
Mr. Steven Schraga, President
Stat Medical Devices, Inc.
2056 NE 153rd Street
Miami, FL 33162 U.S.A.
RE: Warning Letter Close-Out Letter – FEI 1000525253
CMS Case ID: 473754, CMS WA ID: 144791
Dear Mr. Schraga:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-15-29, dated July 23, 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/
Rafael Padilla
Acting Program Division Director
Division of Medical Devices and
Radiological Health Operations II Central
Content current as of:
03/29/2018
CLOSEOUT LETTER
Stoney Ridge Farm, LLC
MARCS-CMS 517412 —
April 02, 2018
Recipient:
Stoney Ridge Farm, LLC
United States
Issuing Office:
United States
Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021
April 2, 2018
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
Derek B. Gavette, Partner
Stoney Ridge Farm, LLC
2092 Van Dyk Road
Everson, Washington 98247
Dear Mr. Gavette:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 17-10, dated April 18, 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:
04/03/2018
CLOSEOUT LETTER
Sucesores De Esmoris & Co., Inc.
MARCS-CMS 518991 —
January 02, 2018
Recipient:
Recipient Name
Mr. James Fox
Recipient Title
President
Sucesores De Esmoris & Co., Inc.
Sucesores De Esmoris & Co., Inc.
5 Comercio St
Mayaguez
,
PR
00680
United States
Issuing Office:
United States
787-729-8500
Office of
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-850
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
January 2, 2018
18-HAFE4-WLCOL-02
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Mr. James J. Fox, President
Sucesores de Esmoris & Co., Inc.
5 Comercio St.
Mayagüez, Puerto Rico 00680
Re: Warning Letter, 17-SJN-WL-05 dated 03/07/2017
Dear Mr. Fox:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, 17-SJN-WL-05, dated 03/07/2017. 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/
Beira Montalvo
Acting, Director of Compliance Branch
OHAFO East Division IV
Content current as of:
01/04/2018
CLOSEOUT LETTER
Sugoi LLC
MARCS-CMS 552810 —
July 13, 2018
Recipient:
Sugoi LLC
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 13, 2018
VIA Electronic Mail
Albert Shu and Jason Lee
Sugoi LLC
d/b/a Sugoi Vapor
albert@sugoivapor.com
RE: Warning Letter issued to Sugoi LLC d/b/a Sugoi Vapor (RW1800845)
Dear Albert Shu and Jason Lee:
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 Pink Sticks 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 Pink Sticks 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 Pink Sticks e-liquid from your website.
On May 3, 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:
Sugoi LLC d/b/a Sugoi Vapor
Attn: Albert Shu
6216 Harvey Way
San Gabriel, CA 91775
Jason Lee
lamborarijason@gmail.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Sunergized LLC
MARCS-CMS 548703 —
June 19, 2018
Recipient:
Sunergized LLC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 19, 2018
James Scarmozzino, Owner
Sunergized LLC
217 Woodbury Rd #84
Woodbury, NY 11797
Dear Mr. James Scarmozzino:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #548703, 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, MPH, RD
Acting 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:
06/26/2018
CLOSEOUT LETTER
Suntraco Food Industries SDN BHD
MARCS-CMS 545371 —
May 10, 2018
Delivery Method:
Electronic Mail
Recipient:
Recipient Name
Tang Hang Seng
Recipient Title
Managing Director
Suntraco Food Industries SDN BHD
Suntraco Food Industries SDN BHD
No. 1 & 3 JLN Korporat 3KU9
Taman Perindustrian Neru
42200
Klang
Selangor
Malaysia
hs.tang@suntracofood.com
Issuing Office:
United States
Dear Seng:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #545371, issued February 8, 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/
Robyn Jones, Team Leader
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/25/2018