tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Drip More LLC
MARCS-CMS 548401 —
July 31, 2018
Recipient:
Drip More LLC
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
Brian Bereber
Drip More LLC
1110 Palmyrita Ave Ste 120
Riverside, CA 92507
dripmore@gmail.com
RE: Warning Letter issued to Drip More LLC(RW1800843)
Dear Brian Bereber:
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 Candy King Batch and Candy King Sour Worms e-liquid products are 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 Candy King Batch and Candy King Sour Worms e-liquids are misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the products to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On May 11, 2018, June 7, 2018, June 8, 2018, June 21, 2018, and July 17, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on June 7, 2018 and July 17, 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 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:
Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW
Washington, DC 20001
chowdhury@khlaw.com
Brian Bereber
Brian.allstarglass@gmail.com
Drip More LLC
irene@dripmore.com
Godaddy.com LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
E Juice Forty
MARCS-CMS 563177 —
October 30, 2018
Delivery Method:
Electronic Mail
Reference #:
1800958
Recipient:
Recipient Name
Mario Ghabour
E Juice Forty
United States
mario.qhabour@hotmail.com
info@ejuiceforty.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mario Ghabour:
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 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. 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.
On September 12, 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 violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
WhoisGuard Protected
WhoisGuard, Inc.
a54ef8dcf4064090a3ecc62468b47b2e.protect@whoisguard.com
NameCheap Inc.
abuse@namecheap.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
04/05/2019
CLOSEOUT LETTER
E-Juice Vapor, Inc.
MARCS-CMS 562933 —
October 26, 2018
Delivery Method:
UPS and Electronic Mail
Reference #:
1800937
Recipient:
Recipient Name
Ala Abufarie
E-Juice Vapor, Inc.
16520 Harbor Blvd Unit D
Fountain Valley
,
CA
92708
United States
cs@ejuicevapor.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Ala Abufarie:
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 Sour Worms 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 Candy King Sour Worms 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 September 28, 2018 and September 28, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on October 18, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
04/05/2019
CLOSEOUT LETTER
Elite Vaporworks
MARCS-CMS 553054 —
July 13, 2018
Recipient:
Elite Vaporworks
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
Jayson Vaughn
Elite Vaporworks
1905 Schuetz Road
St. Louis, MO 63146
info@elitevaporworks.com
RE: Warning Letter issued to Elite Vaporworks (RW1800855)
Dear Jayson Vaughn:
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
.
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). 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. FDA also determined that a person younger than 18 years of age was able to purchase Whip’d Strawberry e-liquid from your website.
On July 11, 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.
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:
Jayson Vaughn
2306 Ball Drive
St. Louis, MO 63146
jaysonvaughn@gmail.com
Timothy Vaughn
Elite Vaporworks, LLC
26 Stone Mill Lane
St. Peters, MO 63376
GoDaddy.com, LLC
abuse@godaddy.com
DigitalOcean, LLC
abuse@digitalocean.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Emmett F. Branigan, MD, PS, Inc
MARCS-CMS 548705 —
July 05, 2018
Recipient:
Emmett F. Branigan, MD, PS, Inc
United States
Issuing Office:
United States
Office of Biological Products Operations
Division II Compliance Branch
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
July 05, 2018
Emmett Branigan, MD
Owner/Medical Director
Emmett F Branigan, M.D., P.S., Inc.
Bellingham, WA 98225
Dear Dr. Branigan:
The Food and Drug Administration has completed an evaluation of (your/your firm’s) corrective actions in response to our Warning Letter #OBPO 18-03, dated 05/07/2018. 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/
Captain Daniel W. Cline, USPHS (Ret)
Compliance Officer
Office of Biological Products Operations
Division II Compliance Branch
Content current as of:
07/06/2018
CLOSEOUT LETTER
Empacadora Diamante S.A.
February 14, 2018
Recipient:
Empacadora Diamante S.A.
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
February 14, 2018
Ms. Victoria Ross, General Manager
Empacadora Diamante S.A.
Km 2 via Atacames
Esmeraldas, Ecuador
Dear Ms. Ross:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #411405, issued November 26, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/15/2018
CLOSEOUT LETTER
Empower Clinic Services, LLC
MARCS-CMS 516718 —
October 22, 2018
Delivery Method:
UPS OVERNIGHT MAIL
Reference #:
3011887629
Recipient:
Recipient Name
Arta Shaun Noorian
Recipient Title
Owner
Empower Clinic Services, LLC
Empower Clinic Services, LLC
5980 West Sam Houston Parkway North
Suite 300
Houston
,
TX
77041
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
4040 N. Central Expressway
Suite 300
Dallas
,
TX
75204
United States
(214) 253-5200
Mr. Noorian,
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (Reference CMS Case #516718) dated May 25, 2017. From November 9, 2015, to November 25, 2015, FDA investigators conducted an inspection of your facility, Empower Clinic Services, LLC, located at 12123 Jones Rd., Houston, Texas 77070. We acknowledge that your firm ceased compounding operations on April 2, 2016 and moved to its newly constructed facility located at 5980 West Sam Houston Pkwy North, Suite 300, Houston, Texas 77041, and registered as a 503B outsourcing facility on July 16, 2016.
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 about this letter, you may contact me by e-mail at
John.Diehl@fda.hhs.gov
or by phone 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:
10/25/2018
CLOSEOUT LETTER
Enclara Pharmacia Inc
MARCS-CMS 513262 —
January 19, 2018
Recipient:
Enclara Pharmacia Inc
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone:
(973) 331-4900
FAX:
(973) 331-4969
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
January 19, 2018
John R. Loxterman
Vice President, Chief Compliance Officer
Enclara Pharmacia, Inc.
512 Elmwood Avenue
Sharon Hill, PA 19079-1014
Dear Mr. Loxterman:
This letter acknowledges receipt of your letter dated April 11, 2017, in which you responded to FDA’s warning letter (ref: WL# 17-PHI-09) dated March 29, 2017. We acknowledge your statement that your firm no longer produces sterile drug products. Therefore, it appears that you have adequately addressed the violations contained in this warning letter.
We note that in your response you stated that the warning letter alleged that your facility was deficient with regards to current good manufacturing practice (CGMP) requirements. As our letter states, the conditions observed during our inspection and described in the warning letter are violations of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act. Regardless of whether your firm meets the conditions of section 503A and qualifies for the exemption from compliance with CGMP requirements, drug products prepared, packed, or held under insanitary conditions are adulterated. For additional information on insanitary conditions, we direct you to our draft guidance, Insanitary Conditions at Compounding Facilities, at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM514666.pdf
. This guidance, if finalized, would provide additional guidance to pharmacies and State regulatory agencies in identifying insanitary conditions in compounding facilities.
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/
Yvette Johnson
Compliance Officer – PHRM1- CB
Content current as of:
01/23/2018
CLOSEOUT LETTER
Eric Cherne
April 26, 2018
Recipient:
Eric Cherne
United States
Issuing Office:
United States
Office of Human and Animal Food –
West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100
April 26, 2018
DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER
Scott N. Cherne, Owner
Eric Cherne, Owner
33166 Kiln Road
Guttenberg, IA 52052
Dear Mr. Scott Cherne and Mr. Eric Cherne:
The Food and Drug Administration has completed an evaluation of Eric Cherne corrective actions in response to our Warning Letter (CMS case #: 497714) on June 27, 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
05/02/2018
CLOSEOUT LETTER
Euro Diagnostica AB
MARCS-CMS 524316 —
September 14, 2018
Product:
Medical Devices
Recipient:
Recipient Name
Ronald E. Long
Recipient Title
CEO
Euro Diagnostica AB
Box 50117
Lundavagen 151
20211
Malmo, Skane Lan
Sweden
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Long:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS#524316] dated September 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/
Donald J. St. Pierre
Acting Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Content current as of:
05/09/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Evanger's Dog & Cat Food Co
MARCS-CMS 518544 —
February 16, 2018
Recipient:
Evanger's Dog & Cat Food Co
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 16, 2018
VIA UPS
Ms. Holly N. Sher, President
Mr. Joel A. Sher, Vice President
Evanger’s Dog & Cat Food Company, Inc.
2210 West 162nd Street
Markham, IL 60428
Dear Mr. and Ms. Sher,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, FY17-HAFE6-01, dated June 29, 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 actions should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Byron J. Ho, DVM
Compliance Officer
Office of Human and Animal Food, Division East 6
Content current as of:
02/21/2018
CLOSEOUT LETTER
F. Rozzo & Sons, Inc.
MARCS-CMS 534445 —
June 26, 2018
Recipient:
F. Rozzo & Sons, Inc.
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 26, 2018
Mr. Louis Rozzo, President/ Co-owner
F. Rozzo & Sons, Inc.
159 9th Avenue
New York, NY 10011-4903
Dear Mr. Rozzo:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 534445, issued on August 21, 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:
06/26/2018