tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Huntington Beach Vape Shop
MARCS-CMS 562781 —
October 24, 2018
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
1800927
Product:
Tobacco
Recipient:
Recipient Name
Jim Petty
Huntington Beach Vape Shop
365 Pilot Road
Suite B
Las Vegas
,
NV
89119
United States
jim.petty@icloud.com
iyad.sabbah77@gmail.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Jim Petty:
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. 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.
On September 19, 2018 and October 2, 2018, you sent FDA a response to the Warning Letter. In response to the Warning Letter, you stated 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 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:
Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
chowdhury@khlaw.com
GoDaddy, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
04/11/2019
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
INCYTO CO., LTD.
MARCS-CMS 497916 —
October 25, 2018
Product:
Medical Devices
Recipient:
Recipient Name
Shane Cho
Recipient Title
Chief Executive Officer
INCYTO CO., LTD.
112, Seonggeo-Gil
Seonggeo-Eup
Seobuk-gu
Cheonan-si
Chungcheongnam-do
31044
South Korea
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Cho:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS#497916] dated September 8, 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/
Scott Gonzalez
Acting Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
CC (US Agent):
Priscilla Chung
LK Consulting Group USA, Inc.
2651 E Chapman Ave
Ste 110 Fullerton, CA 92831
Content current as of:
11/01/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Innovita, LLC
MARCS-CMS 521883 —
July 23, 2018
Product:
Food & Beverages
Recipient:
Recipient Name
Anil K. Bhaskar
Recipient Title
CEO/Owner
Innovita, LLC
Biovation Labs, LLC
2323 S 3600 W
West Valley
,
UT
84119
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Bhaskar:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter DEN-11-06-WL, issued on December 28, 2010 to your company Novacare, LLC (TSN Labs), now Biovation Labs, LLC. 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/
LaTonya M. Mitchell
Denver District Director
Program Division Director
Office of Human and Animal Foods
Division IV West (HAF4W)
Cc:  Justin L. Bath, President
Biovation Labs, LLC
2323 S 3600 W
Salt Lake City, UT 84119
Content current as of:
05/31/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Intensive Nutrition Incorporated
MARCS-CMS 395974 —
October 09, 2018
Product:
Dietary Supplements
Recipient:
Recipient Name
Olivia B. Melaugh
Recipient Title
President
Intensive Nutrition Incorporated
Intensive Nutrition Incorporated
1972 Republic Ave.
San Leandro
,
CA
94577-4224
United States
Issuing Office:
OHAFO West Division 5
1431 Harbor Bay Parkway
Alameda
,
CA
94502
United States
October 9, 2018
RE: WL Close-Out Letter
Dear Ms. Melaugh:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated January 22, 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,
/S/
Sergio Chavez
Director Compliance Branch
Food and Drug Administration
HAF Division West 5
Content current as of:
10/11/2018
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
International Medsurg Connection, Inc.
MARCS-CMS 511426 —
October 16, 2018
Recipient:
Recipient Name
Omi Bhati
Recipient Title
President
International Medsurg Connection, Inc.
935 N Plum Grove Road Suite F
Schaumburg
,
IL
60173-4770
United States
Issuing Office:
Center for Devices and Radiological Health
550 W. Jackson Blvd.
15th Floor
Chicago
,
IL
60661
United States
Dear Dr. Bhati:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-09-118 dated May 08, 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
OMDRHO Division 2 - Central
CC:  Kane Ouano, Quality Compliance Manager
: Dean Sprake Jones, Quality Manager
Content current as of:
10/16/2018
CLOSEOUT LETTER
Ital Lemon
MARCS-CMS 494240 —
January 10, 2018
Recipient:
Ital Lemon
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
January 10, 2018
Mr. Virginio Bersani, General Manager
Ital Lemon S.P.A.
Via Filippo Turati, 2/4
Z.I. Mirandolina
Codogno (Lodi) 26845, Italy
Dear: Mr. Bersani:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 494240, issued May 16, 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:
01/10/2018
CLOSEOUT LETTER
JD & SN Inc., dba Moses Lake Professional Pharmacy
MARCS-CMS 485637 —
August 09, 2018
Recipient:
JD & SN Inc., dba Moses Lake Professional Pharmacy
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road, Irvine, CA 92612
Telephone:
(949) 608-2900
Fax:
(949) 608-4417
August 9, 2018
Shawn W. Needham, R.Ph., President
JD & SN Inc., dba Moses Lake Professional Pharmacy
1555 Pilgrim St.
Moses Lake, Washington 98837-4623
Dear Mr. Needham:
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 October 14, 2016. From June 28, 2017, to July 12, 2017, an FDA investigator conducted a follow-up inspection of your facility, JD & SN Inc., dba Moses Lake Professional Pharmacy, located at 1555 Pilgrim St., Moses Lake, Washington 98837-4623.
We acknowledge that your firm receives valid prescriptions for individually-identified patients for all of the drug products you produce. We also acknowledge that your firm no longer produces sterile drug products or drug products containing domperidone. 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/
CAPT Katherine Jacobitz
Acting Director, Division of Pharmaceutical Quality Operations IV
FEI 3004603767
CMS 485637
Content current as of:
09/18/2018
CLOSEOUT LETTER
Jeffreys Drug Store
MARCS-CMS 495144 —
August 16, 2018
Recipient:
Jeffreys Drug Store
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd Floor
Parsippany, NJ 07054
Telephone:
(973) 331-4900
FAX:
(973) 331-4969
VIA UNITED PARCEL SERVICE
August 16, 2018
Gerald E. O’Hare, R. Ph.
President
Jeffreys Drug Store
1 N. Central Avenue
Canonsburg, PA 15371
Dear Mr. O’Hare:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-PHI-12 dated August 25, 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/
Stephanie Durso
OPQO Division I Director Compliance Branch
Content current as of:
09/17/2018
CLOSEOUT LETTER
K & B Company Inc.
MARCS-CMS 528522 —
September 12, 2018
Delivery Method:
UPS Overnight
Recipient:
Recipient Name
Brent A. Bischoff
Recipient Title
President
K & B Company Inc.
K & B Company Inc.
109 Arnold St.
Gallup
,
NM
87301
United States
Issuing Office:
Office of Human and Animal Foods-Division IV West
United States
September 12, 2018
WARNING LETTER CLOSE-OUT
VIA UPS overnight
Brent A. Bischoff
President
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301
Dear Mr. Bischoff:
The Food and Drug Administration has completed an evaluation of K & B Company's corrective actions in response to our Warning Letter HAF4W(DEN)-17-09-WL (DR) dated July 5, 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/
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods - Division IV West
Content current as of:
10/01/2018
CLOSEOUT LETTER
KCE LLC
MARCS-CMS 492660 —
March 02, 2018
Recipient:
KCE LLC
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway, Alameda, CA 94502
Telephone:
510-337-6700
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
March 2, 2018
Allan M. Yoza, Owner
KCE, L.L.C.
13-1399 Kamaili Rd.
Pahoa, HI 96778
P.O. Box 5884
Hilo, HI 96720
RE: WL #492660 Close-Out Letter
Dear Mr. Yoza:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [WL#492660 issued August 26, 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/
Darla Bracy, District Director
Office of Human and Animal Food
Division 5 West
Content current as of:
03/21/2018
CLOSEOUT LETTER
King of Pops
MARCS-CMS 532713 —
January 12, 2018
Recipient:
King of Pops
United States
Issuing Office:
United States
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
January 12, 2018
Nicholas Carse, COO
Steven Carse, CEO
King of Pops, LLC
337 Elizabeth Street, NE, Suite B
Atlanta, GA 30307
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter [17-ATL-10 dated August 3, 2017]. Based on our evaluation during the December 4, 2017 visit to your facility, 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.
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 Compliance Officer 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:
02/08/2018
CLOSEOUT LETTER
Kohman Dairy LLC
MARCS-CMS 498666 —
April 26, 2018
Recipient:
Kohman Dairy LLC
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
George E. Kohman, Owner
Kohman Dairy
8300 E. Highway 50
Syracuse, KS 67878
Dear Mr. Kohman:
The Food and Drug Administration has completed an evaluation of Kohman Dairy corrective actions in response to our Warning Letter (CMS case #: 498666) on June 23, 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
Kosher Vitamin Express
March 01, 2018
Recipient:
Kosher Vitamin Express
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
March 1, 2018
Abraham Landau
ben@koshervitamins.com
www.koshervitamins.com
Dear Mr. Landau:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 392451, issued February 11, 2013. 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:
03/05/2018
CLOSEOUT LETTER
Leiter's Enterprises, Inc. dba Leiter's
MARCS-CMS 477540 —
May 29, 2018
Recipient:
Leiter's Enterprises, Inc. dba Leiter's
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road, Irvine, CA 92612
Telephone:
(949) 608-2900
Fax:
(949) 608-4417
May 29, 2018
Robin Smith Hoke, President and CEO
Leiter’s Enterprises, Inc. dba Leiter’s
17 Great Oaks Blvd.
San Jose, CA 95119-1359
Dear Ms. Hoke:
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# 477540), dated February 29, 2016. From June 7, 2017, to June 15, 2017, an FDA investigator conducted a reinspection of your facility, Leiter’s Enterprises, Inc. dba Leiter’s, located at 17 Great Oaks Blvd., San Jose, CA 95119-1359. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
06/07/2018
CLOSEOUT LETTER
Lincare, Inc.
MARCS-CMS 492840 —
March 05, 2018
Recipient:
Lincare, Inc.
United States
Issuing Office:
United States
Office of Pharmaceutical Quality Operations, Division II
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
March 5, 2018
VIA UPS EXPRESS
Gregory McCarthy, CEO
Lincare Holdings, Inc.
19387 US 19 N
Clearwater, Florida 33764-3102
Dear Mr. McCarthy:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #2016-DAL-WL-19 dated April 25, 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.
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
Cc: Chelsey Chandler, Center Manager
Lincare, Inc. dba United Medical Home Infusion
1527 S. Bowman Road, Suite D
Little Rock, Arkansas 72211-4200
Content current as of:
03/07/2018