tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Ramirez & Ca. (Filhos)
MARCS-CMS 547978 —
October 16, 2018
Product:
Food & Beverages
Recipient:
Recipient Name
Paulo Vaz Machado
Ramirez & Ca. (Filhos)
Rua do Passadouro, 135, P.O. Box 2050
Matosinhos
4451-953
Porto
Portugal
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Paulo Vaz Machado:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 547978, issued May 3, 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/
Maria Corpuz
Team Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/20/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Raritan Pharmaceuticals, Inc.
MARCS-CMS 516099 —
March 12, 2018
Recipient:
Raritan Pharmaceuticals, 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
March 12, 2018
VIA UPS Next Day Air
Dr. Vin K. Nayak
President
Raritan Pharmaceuticals, Inc.
8 Joanna Ct.
East Brunswick, New Jersey 08816
Dear Dr. Nayak:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-NWJ-09, dated June 20, 2017. Based on our evaluation, 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 it 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/
Liatte Krueger Closs
Compliance Officer
OPQO/PHRM1-CB
Content current as of:
03/12/2018
CLOSEOUT LETTER
Reishi D. International, Inc.
MARCS-CMS 537352 —
November 27, 2018
Product:
Dietary Supplements
Recipient:
Recipient Name
Zheng Xiong Li
Recipient Title
CEO
Reishi D. International, Inc.
451 Victory Ave
Suite 3
South San Francisco
,
CA
94080
United States
Issuing Office:
Office Human and Animal Foods Division West 5
1431 Harbor Bay Parkway
Alameda
,
CA
94502-7070
United States
Dear Mr. Zheng Xiong Li:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 537352), dated February 06, 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/
Robert B. Mcnab
for/
Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5
Content current as of:
10/08/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Rhodes Food Group Ltd.
MARCS-CMS 538029 —
October 05, 2018
Recipient:
Recipient Name
Jurgens Bence
Recipient Title
Operations Manager
Rhodes Food Group Ltd.
Rhodes Food Group Ltd.
8 Industrial Street
Wellington
Western Cape
7655
South Africa
Issuing Office:
Public Health Service
United States
Dear Mr. Bence:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #538029, issued October 6, 2017. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
Brandon Bridgman
/S/
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/25/2018
CLOSEOUT LETTER
Ropack, Inc.
MARCS-CMS 499580 —
April 23, 2018
Recipient:
Ropack, Inc.
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
April 23, 2018
Yves Massicotte
President and Chief Executive Officer
Ropack, Inc.
10801 Mirabeau Street
Montreal H1J 1T7
Canada
Dear Mr. Massicotte:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS # 499580, dated August 3, 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health
Content current as of:
05/08/2018
CLOSEOUT LETTER
Sachau, Jake
MARCS-CMS 489288 —
April 26, 2018
Recipient:
Sachau, Jake
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
Jakob D. Sachau, Owner
Jake Sachau
2441 I Avenue
Denison, IA 51442
Dear Mr. Sachau:
The Food and Drug Administration has completed an evaluation of Jake Sachau corrective actions in response to our Warning Letter (CMS case #: 489288) on February 28, 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
Sagemax Bioceramics, Inc.
MARCS-CMS 439941 —
February 15, 2018
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Sheng Dang
Recipient Title
President and Owner
Sagemax Bioceramics, Inc.
34210 9th Avenue South
Ste. 118
Federal Way
,
WA
98003
United States
Issuing Office:
Division of Medical Device and Radiological Health Operations West
United States
Dear Mr. Dang:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (SEA #15-06), dated 12/09/2014. 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:
01/15/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Santos Agency Inc.
MARCS-CMS 521298 —
April 02, 2018
Recipient:
Santos Agency Inc.
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
April 02, 2018
Mr. Santos Parmar, Manager
Santo Agency Inc.
1188 Montague Street
San Leandro, CA 94577
Dear Mr. Santos Parmar:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 521298), dated April 03, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in thisWarning 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 Compliancegiant
Content current as of:
04/03/2018
CLOSEOUT LETTER
SaveWay Compounding Pharmacy, Inc.
March 28, 2018
Recipient:
SaveWay Compounding Pharmacy, 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
March 28, 2018
Brenda L. Poland Vice President
SaveWay Compounding Pharmacy, Inc.
31 Albe Drive, Suite 1
Newark, DE 19702-1360
Dear Ms. Poland:
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 #17-PHI-01) dated October 4, 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/
Yvette Johnson, Compliance Officer
Office of Pharmaceutical Quality Operations, Division I
Philadelphia District Office
Content current as of:
03/29/2018
CLOSEOUT LETTER
Seafood Wholesalers, Limited
February 27, 2018
Recipient:
Seafood Wholesalers, Limited
United States
Issuing Office:
United States
Office of Human & Animal Food Operations, West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204
February 27, 2018
UPS Overnight
Shafik Islam, President & CEO
Seafood Wholesalers, Ltd.
6o6oB Southwest Freeway
Houston, Texas 77057
Dear Mr. Islam:
The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter (2013-DAL-WL-043, July 29, 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/
Chad J. Whitwell
Acting Director, Compliance Branch
Human & Animal Food Operations, WD3
Content current as of:
02/28/2018
CLOSEOUT LETTER
Seiki Co., Ltd.
MARCS-CMS 523744 —
March 28, 2018
Recipient:
Seiki Co., Ltd.
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
March 28, 2018
Mr. Kenji Kuroiwa
President
Seiki Co., Ltd.
7922-3 Kiire Maenohama-Cho
Kagoshima City, Kagoshima Prefecture
Japan 891-0205
Dear Mr. Kuroiwa:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #523744, issued June 1, 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/
Maria Corpuz
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
04/02/2018
CLOSEOUT LETTER
Sewaren Innovative Pharmaceutical Packaging dba SIPP
MARCS-CMS 513186 —
February 01, 2018
Recipient:
Sewaren Innovative Pharmaceutical Packaging dba SIPP
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
February 1, 2018
VIA UPS NEXT DAY AIR
Hank Incognito, Owner
Sewaren Innovative Pharmaceutical Packaging dba SIPP
994 Rahway Avenue Suite 1
Avenel, NJ 07001-1946
Dear Mr. Incognito:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s May 31, 2017 response to our warning letter WL # 17-NWJ-02 dated May 22, 2017. We acknowledge that your firm ceased drug production at this facility.
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/
Diana Amador Toro
Division Director/OPQ Division 1
New Jersey District Office
Content current as of:
02/14/2018
CLOSEOUT LETTER
Sherman's 1400 Broadway, N.Y.C. LLC.
MARCS-CMS 475207 —
February 23, 2018
Recipient:
Sherman's 1400 Broadway, N.Y.C. LLC.
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
FEB 23, 2018
VIA UPS
William M. Sherman
Executive Vice President
Sherman's 1400 Broadway N.Y.C., Ltd.
10 Sterling Blvd.
3rd Floor
Englewood, NJ 07631
RE: Warning Letter issued to Sherman's 1400 Broadway N.Y.C. LLC (Nat Sherman) (RW1500346)
Dear Mr. Sherman:
On August 27, 2015, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter for the sale or distribution of modified risk tobacco products without an FDA order in effect that permits such sale or distribution, in violation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, you sold or distributed Nat Sherman cigarette products described in product labeling as "Natural."
In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter. You also submitted revised labeling and advertising for your products pursuant to section 905(i) of the Federal Food, Drug, and Cosmetic Act.
FDA conducted an inspection of your manufacturing facility to confirm your corrective actions. After reviewing the results of this inspection, it appears that you have addressed 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.
Sincerely,
/S/
Ele Ibarra-Pratt
Director
Division of Promotion, Advertising and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
02/28/2018
CLOSEOUT LETTER
Shin Ho Sing Ocean Enterprise Co., Ltd.
MARCS-CMS 506326 —
October 05, 2018
Recipient:
Recipient Name
Martin K. L. Lin
Recipient Title
Assistant General Manager
Shin Ho Sing Ocean Enterprise Co., Ltd.
Shin Ho Sing Ocean Enterprise Co., Ltd.
No. 31 Fishing Harbor
South 1st Road
Kaohsiung City
806
Taiwan
Issuing Office:
Public Health Service
United States
Dear Mr. Lin:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #506326, issued September 30, 2016. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter.  Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Brandon Bridgman
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/09/2018
CLOSEOUT LETTER
SIA "Piejura"
MARCS-CMS 557305 —
November 29, 2018
Recipient:
Recipient Name
Mihails Silovs
Recipient Title
Manager
SIA "Piejura"
SIA "Piejura"
Nicas pagasts
Nicas novads
Avoti Liepajas Aprinkis 3473
,
Latvia
Issuing Office:
United States
Dear Mr. Silovs:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 557305 issued on July 3, 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/
Robyn Jones,
Team Leader
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
12/04/2018
CLOSEOUT LETTER
Sixdog Investments, LLC
MARCS-CMS 433264 —
August 01, 2018
Delivery Method:
Certified Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Nicholas DiGorgio
Sixdog Investments, LLC
PO Box 178
Occidental
,
CA
95465
United States
Issuing Office:
Office of Human and Animal Food Operations Division IV West
6th Ave & Kipling St
P.O. Box 25087
Denver
,
CO
80225
United States
Dear Mr. DiGorgio:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-15-03-WL, dated November 3, 2014. 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
Program Division Director
Office of Human and Animal Food Operations -
Division IV West
Content current as of:
10/08/2019
Regulated Product(s)
Food & Beverages