tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
CV7 Holdings LLC
MARCS-CMS 552109 —
February 15, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Amanda Sotta
Recipient Title
Manager
CV7 Holdings LLC
1818 SW 1st Street
Miami
,
FL
33129
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Sotta:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #552109, 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
Branch Chief
Dietary Supplement and Labeling Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/25/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Diamond Head Seafood Wholesale, Inc.
MARCS-CMS 415285 —
April 12, 2019
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Michael P. Irish
Recipient Title
CEO
Diamond Head Seafood Wholesale, Inc.
Nobuo T. Hawaii
966 Robello Lane
Honolulu
,
HI
96817
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
1431 Harbor Bay Parkway
Alameda
,
CA
94502
United States
510-337-6700
Dear Mr. Irish:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning LetterWL # 415285, issued January 3, 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, Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
04/24/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
DK Vitamins
MARCS-CMS 566205 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Maria Salute
DK Vitamins
999 Pope St NW
Palm Bay
,
FL
32907-7757
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Salute:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 566205, issued February 5, 2019. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/06/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Dolezal Dairy
MARCS-CMS 558107 —
August 27, 2019
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jeffery A. Dolezal, Mark G. Dolezal, Mark R. Dolezal
Recipient Title
Co-Owners
Dolezal Dairy
947 - 24th Road
Pender
,
NE
68047
United States
Issuing Office:
Center for Veterinary Medicine
8050 Marshall Drive
Suite 205
Lenexa
,
KS
66214-1524
United States
913-495-5100
Dear Messrs. Dolezal
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 558107 dated August 29, 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.
If you have any questions about this letter, please contact Tamara J. Umscheid, Compliance Officer at
(913) 495-5128
or
Tamara.Umscheid@fda.hhs.gov
.
Sincerely,
/S/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
08/28/2019
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Donggang Hongxing Food Co., Ltd.
MARCS-CMS 588707 —
October 21, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Quan Shijie
Recipient Title
General Manager
Donggang Hongxing Food Co., Ltd.
Huangjiatun Group, Taoyuan Village
Xincheng Administrative
Donggang
Liaoning Sheng
,
118300
China
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Quan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 588707, issued August 15, 2019. 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
Team Leader
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/24/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Dongying Tiandong Pharmaceutical Co Ltd
MARCS-CMS 506849 —
January 11, 2019
Recipient:
Recipient Name
Dr. Lei Dong
Recipient Title
General Manager
Dongying Tiandong Pharmaceutical Co Ltd
Dongying Tiandong Pharmaceutical Co Ltd
No. 1236 Nan-er Road
Dongying Qu
Dongying Shi
Shandong Sheng
,
257067
China
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Dong:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-06 dated November 10, 2016. 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 or these corrections.
This letter does not relieve you or your firm from the responsibility or 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/
Rokhsana Jazi
Compliance Officer
Division of Drug Quality II
Content current as of:
03/04/2019
CLOSEOUT LETTER
Down to Earth Solutions, LLC
MARCS-CMS 576999 —
June 17, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
April Starks
Recipient Title
Owner
Down to Earth Solutions, LLC
78 Happy Hollow Rd
Clarksburg
,
WV
26301
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Ms. Starks:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS# 576999, dated April 10, 2019. 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/20/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Drug Depot, Inc., dba APS Pharmacy
MARCS-CMS 501069 —
September 20, 2019
Delivery Method:
UPS Overnight
Product:
Drugs
Recipient:
Recipient Name
Jaime A. Rios
Recipient Title
Co-Owner and President
Drug Depot, Inc., dba APS Pharmacy
34911 US Highway 19 N Ste 600
Palm Harbor
,
FL
34684-1921
United States
Issuing Office:
Center for Drug Evaluation and Research
4040 N. Central Expressway
Suite 300
Dallas
,
TX
75204
United States
Mr. Rios:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL # FLA-17-02; December 15, 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 ensure 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/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
10/24/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Duncan's Botanical Products, Inc.
MARCS-CMS 519077 —
October 11, 2019
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Brent W. Duncan
Recipient Title
Owner and President
Duncan's Botanical Products, Inc.
1231 E. Smithville Road
Bloomington
,
IN
47401
United States
Issuing Office:
Center for Food Safety and Nutrition
550 W. Jackson Blvd.
Suite 1500
Chicago
,
IL
60661
United States
(312) 353-5863
Dear Mr. Duncan,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (2017-DET-06, dated May 8, 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/
Byron Ho, DVM
Compliance Officer
Office of Human and Animal Food
Division East 6
Content current as of:
10/21/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Earth Turns, LLC
MARCS-CMS 566232 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Thomas Schieber
Earth Turns, LLC
16363 Wynncrest Falls Way
Chesterfield
,
MO
63005
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Schieber:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #566232, issued February 5, 2019. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/06/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Earthborn Products, Inc.
MARCS-CMS 367441 —
May 06, 2019
Delivery Method:
United States Postal Service
Product:
Food & Beverages
Recipient:
Recipient Name
Sheri L. Braemer
Recipient Title
Owner
Earthborn Products, Inc.
3603 1st Ave.
Ste. 403
San Diego
,
CA
92103
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
19701 Fairchild
Irvine
,
CA
92612
United States
Dear Ms. Braemer:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated May 2, 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/
Robert B. Mcnab
Acting Director Compliance Branch
Food and Drug Administration
HAF Division West 5
Content current as of:
05/08/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Ebola-C Inc
MARCS-CMS 441929 —
April 03, 2019
Delivery Method:
Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Todd Spinelli
Ebola-C Inc
United States
Spinellico@yahoo.com
Cs_ebola@yahoo.com
www.ebola-c.com
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Spinelli:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 441929, issued November 2014. 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
eflow Nutrition LLC
MARCS-CMS 560787 —
June 17, 2019
Recipient:
Recipient Name
Eric Wolfe
Recipient Title
Founder
eflow Nutrition LLC
949 W 21st St
Upland
,
CA
91784-1270
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Wolfe:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 560787, dated April 10, 2019. 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/18/2020
CLOSEOUT LETTER
Emmbros Overseas Lifestyle PVT LTD.
MARCS-CMS 565631 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Sahil Mehta
Emmbros Overseas Lifestyle PVT LTD.
Plot 296, Industrial Area
Phase - 2
Panchkula
134113
Haryana
India
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Mehta:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 565631, issued February 5, 2019. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/06/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Essential Pharmacy Compounding
MARCS-CMS 489638 —
July 11, 2019
Delivery Method:
UPS Next Day
SIGNATURE CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Justin M. Kohll
Recipient Title
Owner
Essential Pharmacy Compounding
12759 Q Street
Omaha
,
NE
68137
United States
Issuing Office:
Center for Drug Evaluation and Research
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Kohll,
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 March 10, 2016 (Case #489638), which was issued under your firm’s former name, Essential Pharmacy Compounding. 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 ensure 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
Director Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
07/15/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Fagron, Inc
MARCS-CMS 545906 —
June 13, 2019
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Rafael Padilla
Recipient Title
CEO
Fagron, Inc
Fagron BV
Lichtenauerlaan 182
3062 ME
Rotterdam
Netherlands
Issuing Office:
Center for Drug Evaluation and Research
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Padilla:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [Case# 545906] dated August 29, 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
cc: Teresa Fiedler, President
Fagron North America
Fagron Inc.
2400 Pilot Knob Road
St. Paul, MN 55120
Content current as of:
06/17/2019
Regulated Product(s)
Drugs