tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Colon Care Products of PA, LLC
MARCS-CMS 460342 —
October 30, 2018
Product:
Medical Devices
Recipient:
Recipient Name
Arleen Ehritz
Recipient Title
Owner
Colon Care Products of PA, LLC
151 Hoffman Rd
Barto
,
PA
19504
United States
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Ms. Ehritz:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS #460342 dated May 28, 2015. Based on our evaluation, it appears that you have addressed FDA concerns regarding claims 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.
If you have questions relating to this matter, you may contact CDR Jeene Bailey, FNP, MS, RN at
301-796-5770
, or log onto our web site at
www.fda.gov
for general information relating to FDA device requirements.
Sincerely,
/S/
Ann M. Ferriter
Director, Division of Analysis and Program
Operations
Office of Compliance
Center for Devices and Radiological Health
Content current as of:
11/13/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
The Compounding Pharmacy of America
MARCS-CMS 476703 —
November 07, 2018
Delivery Method:
UPS EXPRESS
Recipient:
Recipient Name
Victor A. Poteet, PharmD.
Recipient Title
Chief Executive Officer
The Compounding Pharmacy of America
6216 Highland Place Way
Suite 201-B
Knoxville
,
TN
37919-4068
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
(615) 366-7801
Dr. Poteet:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated June 9, 2016 [WL # 2016-NOL-08]. 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 further questions, you may contact me at (214) 253-5288.
Sincerely,
/S/
LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
03/04/2019
CLOSEOUT LETTER
Cook Inc.
MARCS-CMS 438190 —
September 04, 2018
Delivery Method:
UPS
Product:
Medical Devices
Recipient:
Recipient Name
Derek Voskuil
Recipient Title
Vice President and General Manager
Cook Inc.
750 N Daniels Way
Bloomington
,
IN
47404-9120
United States
Issuing Office:
Center for Devices and Radiological Health
One Montvale Avenue
Stoneham
,
ME
04231
United States
Dear Mr. Voskuil:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 2014-DET-16 (CMS Case 438190), issued on September 16, 2014. 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 yours,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
09/13/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
The Cookie Boys
MARCS-CMS 510024 —
May 31, 2018
Recipient:
The Cookie Boys
United States
Issuing Office:
United States
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
May 31, 2018
Mr. Jeffrey M. Heilman, Owner
The Cookie Boys
1058 Broadway Ave
San Jose, CA 95125
Dear Mr. Jeffrey M. Heilman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 510024), dated March 03, 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:
06/08/2018
CLOSEOUT LETTER
Cosmic Fog Vapors LLC d/b/a Next Day Vapor Products
MARCS-CMS 553063 —
July 13, 2018
Recipient:
Cosmic Fog Vapors LLC d/b/a Next Day Vapor Products
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 13, 2018
VIA UPS and Electronic Mail
Robert Crossley
Cosmic Fog Vapors LLC
d/b/a Next Day Vapor Products
3115 Airway Ave
Costa Mesa, CA 92626
cosmicfogvapors@gmail.com
RE: Warning Letter issued to Cosmic Fog Vapors LLC d/b/a Next Day Vapor Products (RW1800858)
Dear Robert Crossley:
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 Whip’d Strawberry 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 Whip’d Strawberry 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 7, 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 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 Electronic Mail
cc:
Jeffrey Nelson
Cosmic Fog Vapors
jeff@cosmicfogvapors.com
Jonny Tabares
Next Day Vapor Products
jonny@cosmicfogvapors.com
Go Daddy, LLC
abuse@godaddy.com
Amazon Technologies Inc.
abuse@amazonaws.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Cracker King Corp.
MARCS-CMS 528052 —
July 09, 2018
Recipient:
Cracker King Corp.
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
July 9, 2018
Mr. Leonardo C. Morales, President
Cracker King Corp.
307 Peninsula Blvd
Hempstead, NY 11550-4912
Dear Mr. Morales:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 528052, September 15, 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/
CDR Catherine M. Beer
Director of Compliance
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
07/25/2018
CLOSEOUT LETTER
CTX Lifesciences Private Ltd.
MARCS-CMS 496393 —
October 05, 2018
Reference #:
FEI 3006254924
Recipient:
Recipient Name
Kanak Jariwala
Recipient Title
Managing Director
CTX Lifesciences Private Ltd.
CTX Lifesciences Private Ltd.
Block No. 251-252, Sachin-Magdalla Road
GIDC
Sachin, Surat, Gujarat
394230
India
Issuing Office:
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Jariwala:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-17-18 issued on January 18, 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/
LT Loan Chin
Global Compliance Branch 2
Division of Drug Quality I
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
10/30/2018
CLOSEOUT LETTER
DBM Nutrition
MARCS-CMS 483226 —
March 23, 2018
Recipient:
DBM Nutrition
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
March 23, 2018
Darin Booton
DBM Nutrition
203 South Somonauk Road
Cortland, IL 60112
Dear Mr. Booton:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 483226, issued November 30, 2015. Based on our evaluation, it appears 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.
Sincerely,
/S/
Latasha Robinson, M.S.
Branch Chief
Dietary Supplement Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/27/2018
CLOSEOUT LETTER
Denttio, Inc.
MARCS-CMS 508595 —
April 10, 2018
Recipient:
Denttio, Inc.
United States
Issuing Office:
United States
Office of Medical Device and Radiological Health Operations, Division 3
19701 Fairchild Road, Irvine, CA 92612
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
April 10, 2018
Mr. Young Han, President
Denttio, Inc.
116 N. Maryland Ave., Suite 125
Glendale, CA 91206
Dear Mr. Han:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #16-17), dated 02/23/2017. 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:
04/20/2018
CLOSEOUT LETTER
Dherbs Health Emporium Inc.
MARCS-CMS 475507 —
July 03, 2018
Recipient:
Dherbs Health Emporium Inc.
United States
Issuing Office:
United States
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
July 03, 2018
Mr. Ahman Dolphin, CEO
Dherbs Health Emporium Inc.
2734 Fletcher Drive
Los Angeles, CA 90039
Dear Mr. Ahman Dolphin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 475507), dated December 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/
Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5
Content current as of:
07/05/2018
CLOSEOUT LETTER
Diversified Pharmacy Inc dba University Compounding Pharmacy
MARCS-CMS 470499 —
September 12, 2018
Recipient:
Diversified Pharmacy Inc dba University Compounding Pharmacy
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
September 12, 2018
UPS NEXT DAY
SIGNATURE REQUIRED
Joseph J. McCloskey
Owner
Diversified Pharmacy, Inc., dba
University Compounding Pharmacy
2520 Livernois Road
Troy, MI 48083-4703
Dear Mr. McCloskey:
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: WL 2016 DET-07) dated February 26, 2016. 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:
09/18/2018
CLOSEOUT LETTER
D&K Foods
MARCS-CMS 499092 —
October 17, 2018
Product:
Food & Beverages
Recipient:
Recipient Name
Martin Silver
D&K Foods
Side Effect Solutions Corporation dba NoBetes Corporation
13428 Maxella Ave
Suite 631
Marina del Rey
,
CA
90292
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Silver:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #499092, issued September 15, 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/
Carrie J. 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:
07/10/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
DoctorVicks.com
MARCS-CMS 512642 —
February 02, 2018
Recipient:
DoctorVicks.com
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
February 2, 2018
DoctorVicks.com
Attn: Sholom Levitin
2112 59th St.
Brooklyn, NY 11204
28500 Nutwood Lane
Wickliffe, OH 44092
Dear Mr. Levitin:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter NYK-2017-08 dated April 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
02/02/2018
CLOSEOUT LETTER
Domestic Tobacco Company, LLC
MARCS-CMS 510912 —
June 29, 2018
Recipient:
Recipient Name
Lois B. Ranck
Recipient Title
President
Domestic Tobacco Company, LLC
830 N. Prince Street
Lancaster
,
PA
17603
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Ms. Ranck:
The Center for Tobacco Products (CTP) of the United States Food and Drug Administration (FDA) has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated January 19, 2017. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. You have submitted the following to CTP:
• Establishment registration and finished tobacco product listing as required by sections 905(b) and (i) of the Federal Food, Drug , and Cosmetic Act (FD&C Act);
• A listing of all ingredients added to your finished tobacco products, as required by section 904(a)(1) of the FD&C Act; and
• A reporting of harmful and potentially harmful constituents (HPHC) in your finished tobacco products, as required by section 904(a)(3) of the FD&C Act.
Additionally, CTP has reviewed the establishment inspection report (EIR) for a routine inspection of your establishment performed on January 23, 2018. Based on our evaluation of the EIR, it appears that you have addressed CTP's additional observation regarding section 903(a)(2)(D) of the FD&C Act noted in the January 19, 2017, Warning Letter. Specifically, FDA investigators observed during the inspection that your smokeless tobacco product labels, packaging, and shipping containers bear the statement, "Sale only allowed in the United States," as required by section 920(a) of the FD&C Act.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure 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 FDA become aware of any failure to comply with any other violations in the future.
If you have any questions concerning this matter, please contact David Keith at
301-796-2722
or via email at
David.Keith@fda.hhs.gov
.
Sincerely,
/S/
David Keith
Director
Division of Enforcement and Manufacturing
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
10/05/2018
CLOSEOUT LETTER
Douglas Chambers Dairies Inc.
MARCS-CMS 526859 —
August 24, 2018
Recipient:
Douglas Chambers Dairies Inc.
United States
Issuing Office:
United States
60 Eighth Street N.E.
Atlanta, GA 30309
August 24, 2018
Mary Watts, Owner
Douglas Chambers Dairy, Inc.
300 Mayzine Dairy Road
Macon, GA 31217
RE: Warning Letter (17-ATL-11)
Dear Ms. Watts,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter [17-ATL-11 dated September 26, 2017]. Based on our evaluation during the March 6, 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)
Office of Regulatory Affairs
Content current as of:
08/27/2018