tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Pat's Exotic Beverages, Inc.
MARCS-CMS 456025 —
January 23, 2020
Delivery Method:
United Parcel Service
Reference #:
NYK-2015-48
Product:
Food & Beverages
Recipient:
Recipient Name
Cordelia P. Lindsay
Recipient Title
President
Pat's Exotic Beverages, Inc.
2919 Tiemann Avenue
Bronx
,
NY
10469-3321
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Ms. Lindsay:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2015-48, issued on October 7, 2015. 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:
01/30/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Perfect Choice Trading, Inc. & Nutricos Ceuticals, Inc.
MARCS-CMS 569322 —
February 26, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Chan K. Wong
Recipient Title
President
Perfect Choice Trading, Inc. & Nutricos Ceuticals, Inc.
156 Mott Street Bsmt.
New York
,
NY
10013
United States
Issuing Office:
Division of Human and Animal Food Operations East I (HAFE1)
United States
Dear Mr. Wong:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 569322, issued on June 11, 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
02/27/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Perfect Source Natural Products Inc.
MARCS-CMS 495168 —
March 31, 2020
Delivery Method:
United Parcel Service
Reference #:
39-16
Recipient:
Recipient Name
Mr. Andy D. Yurcho
Recipient Title
President
Perfect Source Natural Products Inc.
401 S. Acacia Ave.
Fullerton
,
CA
92831
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Yurcho:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 39-16 dated 8/10/2016. 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/13/2020
CLOSEOUT LETTER
Perla Del Sur Foods L.L.C.
MARCS-CMS 562174 —
January 31, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
20-HAFE4-WLCOL-02
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ernesto Vázquez Borrero
Recipient Title
President
Perla Del Sur Foods L.L.C.
Don Julio Tropical Food LLC
Ext. La Guadalupe
Calle Guadalupe # 62
Ponce
,
PR
00730
United States
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Vázquez Borrero:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to 18-HAFE4-WL-04 dated August 15, 2018. During the current establishment inspection, we were informed that our firm is no longer operational. 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.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
Office of Human and Animal Feed Operations,
East Division IV
Content current as of:
04/28/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Pescatlantic Group, LLC
MARCS-CMS 496990 —
May 26, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WLCOL-09
Product:
Drugs
Recipient:
Recipient Name
Mr. Cesar Calvo
Recipient Title
CEO
Pescatlantic Group, LLC
6100 Blue Lagoon Dr.
Suite #325
Miami
,
FL
33126
United States
shipments@pescatlantic.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Calvo:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, FLA 16-17 dated June 14, 2016. 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 your responsibility of assuring that your establishment is in compliance with the Federal Food, Drug, and Cosmetic Act and its 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, please feel free to contact Ms. Pearl Lopina, Compliance Officer at telephone number
(407) 475-4730
or at e-mail address
pearl.lopina@fda.hhs.gov
.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
05/29/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
POPSALOT, LLC
MARCS-CMS 493726 —
April 30, 2020
Delivery Method:
United Parcel Service
Reference #:
WL #34-16
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Noah H. Sheray
Recipient Title
Principal
POPSALOT, LLC
7723 Somerset Boulevard
Paramount
,
CA
90723-4101
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Sheray:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated June 21, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
05/07/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Pretty Women UK LTD T/A Coil2oil and Mad Kingdom Liquids
MARCS-CMS 610060 —
November 02, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
RW2001418
Recipient:
Recipient Name
Jagmeet Singh
Pretty Women UK LTD T/A Coil2oil and Mad Kingdom Liquids
United States
vape247store@gmail.com
coil2oil@outlook.com
info@oil2coil.co.uk
Issuing Office:
Division of Promotion, Advertising, and Labeling
United States
Dear Jagmeet Singh:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses, dated September 20, 2020 and October 27, 2020, in response to our Warning Letter dated September 9, 2020. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://coil2oil.co.uk and the Instagram account https://www.instagram.com/mad.kingdom/.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic 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/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
11/25/2020
CLOSEOUT LETTER
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
MARCS-CMS 552431 —
March 31, 2020
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
HeeJoo Park, RPh
Recipient Title
President and CEO, COO, CFO
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
530 South 336th Street
Federal Way
,
WA
98003-6383
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
19701 Fairchild
Irvine
,
CA
92612-2506
United States
949-608-2900
Dear Ms. Park:
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# 552431) dated April 4, 2018. 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
04/24/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Ralfy's Emporium
MARCS-CMS 597065 —
October 22, 2020
Delivery Method:
Electronic Mail
Reference #:
RW1901136
Recipient:
Recipient Name
William Stewart
Ralfy's Emporium
United States
info@nor-scot.com
Issuing Office:
Center for Tobacco Products
United States
Dear William Stewart:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated July 17, 2019. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter for the website http://www.nor-scot.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic 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/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
11/05/2020
CLOSEOUT LETTER
Samba Premium Tobacco, Inc.
MARCS-CMS 598724 —
November 02, 2020
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901232
Recipient:
Recipient Name
Sasha Josef Friwat and Samar Itani
Samba Premium Tobacco, Inc.
934 S. Andreasen Dr.
Ste F
Escondido
,
CA
92029
United States
support@sambatobacco.com
sambatobacco@gmail.com
Issuing Office:
Division of Promotion, Advertising, and Labeling
United States
Dear Sasha Josef Friwat and Samar Itani:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated December 20, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.sambatobacco.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic 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/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
11/25/2020
CLOSEOUT LETTER
The Sanapac Co., Inc.
MARCS-CMS 514139 —
April 06, 2020
Recipient:
Recipient Name
Mrs. Darlene Doble
Recipient Title
President
The Sanapac Co., Inc.
524 Orange Road
Dallas
,
PA
18612
United States
Issuing Office:
Human & Animal Food Division East II
United States
Dear Mrs. Doble:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-PHI-07 issued March 24, 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 wit 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/
Robin M. Rivers
Compliance Officer
Human and Animal Food East, Division 2
Content current as of:
04/13/2020
CLOSEOUT LETTER
Santa Monica Seafood dba Los Angeles Fish Company
MARCS-CMS 490907 —
April 20, 2020
Reference #:
22-16
Product:
Food & Beverages
Recipient:
Recipient Name
Hisato (NMI) Doizaki
Recipient Title
General Manager
Santa Monica Seafood dba Los Angeles Fish Company
420 Stanford Ave.
Los Angeles
,
CA
90013-2121
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Doizaki:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #22-16 dated March 7, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/27/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Shadow Holdings dba Bocchi Laboratories
MARCS-CMS 561273 —
January 10, 2020
Delivery Method:
United Parcel Service
Product:
Cosmetics
Recipient:
Recipient Name
Joseph C. Pender
Recipient Title
CEO/President
Shadow Holdings dba Bocchi Laboratories
26421 Ruether Ave
Santa Clarita
,
CA
91350-2621
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
Dear Mr. Pender:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #561273 dated February 6, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
01/15/2020
Regulated Product(s)
Cosmetics
CLOSEOUT LETTER
Shanghai Neo-Medical Import & Export Co., Ltd.
MARCS-CMS 477444 —
June 16, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Pei Zhang
Recipient Title
General Manager
Shanghai Neo-Medical Import & Export Co., Ltd.
Room 2004, B/D3
183 Huai Hai Xi Rd.
Shanghai Shi
,
200000
China
Issuing Office:
Division of Infection Control and Plastic Surgery Devices
United States
Dear Mr. Zhang:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 477444, dated November 10, 2015). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Cynthia J. Chang, Ph.D.
Director
Division of Infection Control and Plastic Surgery
Devices
Office of Health Technology 4: Surgical and
Infection Control Devices
Center for Devices and Radiological Health
CC:
Marco Mu
Mid-link International Inc
2219 Rimlang Drive, Suite 301
Bellingham, WA US 98226
Content current as of:
06/23/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Shoreside Enterprises Inc.
MARCS-CMS 422722 —
May 26, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WLCOL-07
Product:
Drugs
Recipient:
Recipient Name
Mr. Brian Moses
Recipient Title
President
Shoreside Enterprises Inc.
6321 Newtown Cir.
Apt B1
Tampa
,
FL
33615-3615
United States
Shoresideenterprises@yahoo.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Moses:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, FLA-15-09 dated December 23, 2014. 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 your responsibility of assuring that your establishment is in compliance with the Federal Food, Drug, and Cosmetic Act and its 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, please feel free to contact Ms. Pearl Lopina, Compliance Officer at telephone number
(407) 475-4730
or at e-mail address
pearl.lopina@fda.hhs.gov
.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
05/29/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Shree Datt Aquaculture Farms
MARCS-CMS 588773 —
January 06, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Dattubhai Tandel
Recipient Title
Managing Director
Shree Datt Aquaculture Farms
270/1, At & Post Talodh
Bilimora, District Navsari
Taluka-Gandevi
396321
Gujarat
India
Issuing Office:
Office of Compliance
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Tandel:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 588773 issued August 22, 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 Jones
Team Leader
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
01/15/2020
Regulated Product(s)
Food & Beverages