tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Omnia E-Liquid
MARCS-CMS 553221 —
August 22, 2018
Recipient:
Omnia E-Liquid
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
AUG 22, 2018
VIA UPS and Electronic Mail
Michael Eshragh
Omnia E-Liquid
6000 S Eastern Ave, Suite 5E
Las Vegas, NV 89119
michael@omniaeliquid.com
RE: Warning Letter issued to Omnia E-Liquid (RW1800862)
Dear Michael Eshragh:
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 Twirly Pop 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 soldit to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(b)(1). Additionally, the Warning Letter informed you that you violated section 201(rr)(4) of the  FD&C Act by marketing your product in combination with food. Specifically, FDA determined that the labeling and/or advertising of your Twirly Pop 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 Twirly Pop e-liquid from your website. Additionally, FDA determined that you marketed and co-packaged Twirly Pop e-liquid in combination with a food, particularly a lollipop, in violation of section 201(rr)(4) of the FD&C Act.
On May 1, 2018, July 10, 2018, July 31, 2018, August 8, 2018, and August 15, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on June 20, 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.
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
omniaeliquid.com@domainsbyproxy.com
twirlypopeliquid.com@domainsbyproxy.com
GoDaddy.com, Inc.
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/22/2018
CLOSEOUT LETTER
One Chang Corp.
MARCS-CMS 481154 —
November 05, 2018
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Yang Zhou Lu
Recipient Title
President and Owner
One Chang Corp.
839 40th Street
Brooklyn
,
NY
11232-3803
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
Dear Mr. Lu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-2 dated November 10, 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1
Content current as of:
11/13/2018
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Option Care
MARCS-CMS 497963 —
April 12, 2018
Recipient:
Option Care
United States
Issuing Office:
United States
Office of Pharmaceutical Quality Operations, Division 2
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3158
April 12, 2018
John C. Rademacher, Chief Executive Officer
Option Care, Inc.
3000 Lakeside Drive, Suite 300N
Bannockburn, Illinois 60015
Dear Mr. Rademacher:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Ref: 2017-DAL-WL-01] issued on October 19, 2016, following our inspection of your facility, Option Care, Inc., located at 14220 Northbrook Drive, Suite 100B, San Antonio, Texas 78232, from July 20, 2015 to August 6, 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.
If you have any questions regarding this letter, please contact me at
214-253-5288
or via email at
John.Diehl@fda.hhs.gov
.
Sincerely,
/S/
LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
cc:
Mary Lozano
Director of Operations
Option Care, Inc.
14220 Northbrook Drive, Suite 100B
San Antonio, Texas 78232
Content current as of:
04/16/2018
CLOSEOUT LETTER
Option Care, Inc.
MARCS-CMS 454500 —
April 26, 2018
Delivery Method:
UPS Overnight
Reference #:
2015-DAL-WL-29
Product:
Drugs
Recipient:
Recipient Name
John C. Rademacher
Recipient Title
Chief Executive Officer
Option Care, Inc.
3000 Lakeside Drive
Suite 300N
Bannockburn
,
IL
60015
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Rademacher:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Ref: 2015-DAL-WL-29] issued on August 27, 2015, following our inspection of your facility, Option Care, Inc. (formerly Walgreens Infusion Services), located at 9030 Kirby Drive, Houston, Texas 77054, from November 4, 2014 to November 25, 2014. 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.
If you have any questions regarding this letter, please contact Mr. John Diehl, Director, Compliance Branch, at
214-253-5288
or via e-mail at
John.Diehl@fda.hhs.gov
.
Sincerely,
/S/
Mark W. Rivero
for
LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
cc:
Amy F. Groves
Director of Operations
Option Care, Inc.
9030 Kirby Drive
Houston, Texas 77054
Content current as of:
05/21/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Organ Recovery Systems, Inc.
MARCS-CMS 519572 —
November 28, 2018
Recipient:
Recipient Name
David Kravitz
Recipient Title
President and CEO
Organ Recovery Systems, Inc.
Organ Recovery Systems, Inc.
One Pierce Place
Suite 475W
Itasca
,
IL
60143
United States
Issuing Office:
Center for Devices and Radiological Health
550 W. Jackson Blvd.
15th Floor
Chicago
,
IL
60661
United States
Dear Mr. Kravitz:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-07-17 dated April 20, 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/
Blake Bevill, MS
Program Division Director
Office of Medical Device and Radiological Health
OMDRHO Division 2 - Central
CC: Pedro Juan Pardo, Director of Regulatory and Clinical Affairs
: Christopher M. Hill, Director of Quality Assurance
Content current as of:
12/04/2018
CLOSEOUT LETTER
PA Constans - Minnesota Emu
MARCS-CMS 543014 —
December 11, 2018
Recipient:
Recipient Name
Patricia A. Constans
Recipient Title
Owner
PA Constans - Minnesota Emu
24200 Fairwood Lane
Nevis
,
MN
56467-4218
United States
Issuing Office:
Center for Food Safefty and Applied Nutrition
United States
(812) 334-4100
Dear Ms. Constans:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 543014 dated February 23, 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/
Demetria L. Lueneburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
03/04/2019
CLOSEOUT LETTER
Pakco (Pty) Ltd.
February 09, 2018
Recipient:
Pakco (Pty) Ltd.
United States
Issuing Office:
United States
College Park, MD 20740
February 9, 2018
Mr. Gerald King, Managing Director
Pakco (Pty) Ltd.
1 Pakco Street
P.O. Box 65
Verulam, South Africa.4340
Dear Mr. King:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #484504, issued 2/4/2016. 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/
Robyn Jones, Supervisor
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/12/2018
CLOSEOUT LETTER
Pearson Foods Corporation
MARCS-CMS 506517 —
February 20, 2018
Recipient:
Pearson Foods Corporation
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
David C. Pearson, Owner/CEO
Pearson Foods Corporation
1024 Ken-O-Sha Industrial Park Drive, SE
Grand Rapids, MI 49508-8217
Dear Mr. Pearson,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2017-DET-01, dated October 26, 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/
Lisa M. Thursam
Compliance Officer
Human and Animal Food Operations
Division East 6
CC:
Eric W. Pearson, President
Pearson Foods Corporation
1024 Ken-O-Sha Industrial Park Drive, SE
Grand Rapids, MI 49508-8217
Content current as of:
02/22/2018
CLOSEOUT LETTER
Pelvic Therapies, Inc
MARCS-CMS 518409 —
August 07, 2018
Recipient:
Pelvic Therapies, Inc
United States
Issuing Office:
United States
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
August 7, 2018
Ms. Elizabeth Janapol, Owner
Pelvic Therapies, Inc.
390 Oak Ave., Suite G
Carlsbad, CA 92008
Dear Ms. Janapol:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #518409-18), dated 10/17/2017. 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/
Kelly D. Sheppard
Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations
Content current as of:
08/10/2018
CLOSEOUT LETTER
Pentax of America, Inc.
January 26, 2018
Recipient:
Pentax of America, Inc.
United States
Issuing Office:
United States
Office of Medical Device and Radiological Health Operations (Division 1)
One Montvale Avenue
Stoneham, MA 02180
January 26, 2018
David Woods
President
PENTAX of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1725
Dear Mr. Woods,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to the Warning Letter [13-NWJ-06, dated March 29, 2013], issued to KayPENTAX, A Division of PENTAX Medical Company. 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/
Gina Brackett
Acting Director, Compliance Branch
Office of Medical Device and Radiological Health Operations, Division 1
Content current as of:
01/30/2018
CLOSEOUT LETTER
Pesca Fina, S.A.
MARCS-CMS 524192 —
April 16, 2018
Recipient:
Pesca Fina, S.A.
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
April 16, 2018
Mr. Constantino Rusodimos, General Manager
Pesca Fina, S.A.
Port of Vacamonte
Vista Alegre, Arraijan, Panama
Dear Mr. Rusodimos:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #524192, issued July 18, 2017. 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/
Robyn Jones
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
04/20/2018
CLOSEOUT LETTER
Pesquera Nivama SAC
MARCS-CMS 500707 —
January 10, 2018
Recipient:
Pesquera Nivama SAC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
January 10, 2018
Mr. Javier Pacheco Monteverde
Co-Owner / Sales Manager
Pesquera Nivama SAC
Calle: os Zorzales 160, San Isidro
Lima, Peru
Dear: Mr. Monteverde:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 500707, issued August 30, 2016. 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/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
01/12/2018
CLOSEOUT LETTER
Pharmacy Direct, PDU
MARCS-CMS 548625 —
June 19, 2018
Recipient:
Pharmacy Direct, PDU
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 19, 2018
Michael Rowen, President
Pharmacy Direct, Inc.
8 The Green
Suite 5871
Dover, DE 19901
Dear Mr. Michael Rowen:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #548625, 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
Purevive Health Sciences, LLC
MARCS-CMS 489944 —
June 14, 2018
Recipient:
Purevive Health Sciences, LLC
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild, Irvine, CA 92612
Telephone:
949-608-4496
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 14, 2018
Carmen P. Bickell, Owner
Pure Vive Health Sciences, LLC formerly Vitalife, Inc. dba Tabak's Health Products
11258 Monarch St., Ste. L
Garden Grove, CA 92841
RE: WL #33-16 Close-Out Letter
Dear Ms. Bickell:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #33-16, dated June 20, 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/
Sergio Chavez
Director Compliance Branch
Food and Drug Administration
HAF Division West 5
Content current as of:
06/25/2018
CLOSEOUT LETTER
QL FIGO FOODS SDN BHD
February 07, 2018
Recipient:
QL FIGO FOODS SDN BHD
United States
Issuing Office:
United States
College Park, MD 20740
February 7, 2018
Mr. Jasper Liew Meow Fook, Executive Director
QL Figo Johor Sdn. Bhd.
Lot 3627, Batu 22, Jalan Harmoni 1
Kulai, Johor, 81000
Malaysia
Dear: Mr. Jasper Liew Meow Fook:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #440043, issued 11/5/2014. 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/
Mildred Benjamin
Director, Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/08/2018