tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Chongqing Pharma Research Institute Co., Ltd.
MARCS-CMS 515080 —
March 09, 2020
Recipient:
Recipient Name
Mr. Leng Minghui
Recipient Title
Chairman
Chongqing Pharma Research Institute Co., Ltd.
No. 565 Tushan Rd.
Nanan District
Nan'an Qu
Chongqing Shi
,
400061
China
Issuing Office:
Center for Drug Evaluation and Research | CDER
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Leng:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-24 dated February 14, 2017. 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 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 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/
Maan Abduldayem
Branch Chief, GCB2
Division of Drug Quality I
Content current as of:
03/12/2020
CLOSEOUT LETTER
Chukar Cherry Company Inc.
MARCS-CMS 573446 —
May 04, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Pamela Montgomery, John T. Montgomery
Recipient Title
President, Chief Financial Officer
Chukar Cherry Company Inc.
320 Wine Country Road
Prosser
,
WA
99350
United States
Issuing Office:
Seattle District Office
United States
Dear Mrs. and Mr. Montgomery:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 573446, dated June 27, 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/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
05/07/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
City Vapes Premium eJuice Inc.
MARCS-CMS 604021 —
October 22, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
RW1901231
Recipient:
City Vapes Premium eJuice Inc.
United States
sales@cityvapes.com
doitbyecig@shaw.ca
Issuing Office:
Center for Tobacco Products
United States
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 February 28, 2020. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter for the website https://cityvapes.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:
10/26/2020
CLOSEOUT LETTER
Comercial Mares de Chiloe
MARCS-CMS 587913 —
January 31, 2020
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Ignacio Samacoitz
Comercial Mares de Chiloe
Cardonal Bajo 2, 7 Lote 1A
5500000
Puerto Montt
Los Lagos
Chile
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Samacoitz:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #587913, issued August 19, 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 Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/18/2020
Regulated Product(s)
Food & Beverages
Seafood/Seafood Product
CLOSEOUT LETTER
CPAPNEA Medical Supply
MARCS-CMS 592737 —
November 24, 2020
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Sal T. Hakim
Recipient Title
Owner
CPAPNEA Medical Supply
10443 N. Cave Creek Rd, #110
Phoenix
,
AZ
85020-1637
United States
sal@cpapnea.com
Issuing Office:
Office ofMedical Device and Radiological Health Operations Division 3West
United States
Dear Mr. Hakim:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated January 22, 2020. 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/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III
Content current as of:
12/01/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Crafty E-Liquids Limited
MARCS-CMS 609769 —
November 05, 2020
Delivery Method:
VIA Electronic Mail
Recipient:
Recipient Name
Josef Nolan
Crafty E-Liquids Limited
United States
JOE.NOLAN21@GMAIL.COM
info@craftyeliquids.co.nz
CraftyEliquids@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Josef Nolan:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your emails, dated August 2, 2020 and September 17, 2020, in response to our Warning Letter dated July 31, 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://craftyeliquids.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
VIA Electronic Mail
cc:
Dreamscape Networks International Pte Ltd.
abuse@crazydomains.com
domains@crazydomains.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
11/05/2020
CLOSEOUT LETTER
Create-A-Pack Foods, Inc.
MARCS-CMS 532708 —
January 09, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Glenn M. Cochrane
Recipient Title
Owner/President
Create-A-Pack Foods, Inc.
W1344 Industrial Drive
Ixonia
,
WI
53036-9486
United States
Issuing Office:
Division of Human and Animal Food Operations West I (HAFW1)
United States
Dear Mr. Cochrane:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated November 2, 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
01/15/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Custom Assemblies, Inc.
MARCS-CMS 540535 —
June 15, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Mr. William A. J. Peacock
Recipient Title
President
Custom Assemblies, Inc.
330 East Main Street
PO Box 177
Pine Level
,
NC
27568
United States
Jack.Peacock@customassemblies.com
Kathy.Jackl@customassemblies.com
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 2 Central
United States
(407) 475-4700
Dear Mr. Peacock:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 540535 dated April 06, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future 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
Content current as of:
06/29/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Custom Compounding Center
MARCS-CMS 481888 —
October 28, 2020
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Mark W. Shinabery
Recipient Title
Owner and Pharmacist-In-Charge
Custom Compounding Center
11700 Kanis Rd
Suite 1
Little Rock
,
AR
72211
United States
Mark@customccrx.com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Mr. Shinabery:
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-14, dated March 16, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
11/05/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Dandong Shenghai Foodstuff Co. Ltd.
MARCS-CMS 588709 —
January 06, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Jin Tao
Recipient Title
Vice General Manager
Dandong Shenghai Foodstuff Co. Ltd.
Youhao Road East
Qiaonan Economic Development Zone
Donggang
Liaoning Sheng
,
118300
China
Issuing Office:
Office of Compliance
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Jin:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #588709 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 Lead
Food Adulteration Assessment Branch
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
CLOSEOUT LETTER
D'Andrea Foods, Inc.
MARCS-CMS 576292 —
September 08, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Michael D’Andrea
Recipient Title
President and Owner
D'Andrea Foods, Inc.
378 Pleasant St
East Bridgewater
,
MA
02333-1349
United States
Issuing Office:
Office of Human and Animal Food Operations East - Division 1
United States
Dear Mr. D’Andrea:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to ourWarning Letter CMS # 576292 dated March 15, 2019. Based on our evaluation, it appears that you have addressed the violations 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 subsequent inspection or through other means.
Sincerely,
/S/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1
Content current as of:
09/11/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
DeGrave Dairy
MARCS-CMS 515987 —
February 05, 2020
Reference #:
MIN 17-05
Product:
Animal & Veterinary
Recipient:
Recipient Name
Dale DeGrave
Recipient Title
Owner
DeGrave Dairy
E2471 County Road X
Casco
,
WI
54205-9796
United States
Issuing Office:
Office of Human and Animal Foods Operations
United States
(612) 334-4100
Dear Mr. DeGrave:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter MIN 17-05 dated February 27, 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
02/10/2020
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Delori Industrial Co., Ltd.
MARCS-CMS 605380 —
July 02, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jihuan Wu
Recipient Title
President
Delori Industrial Co., Ltd.
NO. 799 Hengshan West Road
Beilun Qu
Ningbo Shi
Zhejiang Sheng
,
315800
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Jihuan Wu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 605380, issued March 10, 2020. 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 G. Corpuz, Team Leader
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/15/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Dodwell Co Inc
MARCS-CMS 491381 —
April 20, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Kevin K. Lau
Recipient Title
Co-Owner
Dodwell Co Inc
435 4th St.
Oakland
,
CA
94607
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
1201 Harbor Bay Parkway
Alameda
,
CA
94502
United States
Dear Mr. Lau:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter March 4, 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
Dorneyville Pharmacy
MARCS-CMS 510866 —
June 22, 2020
Delivery Method:
Via Certified Email
Recipient:
Recipient Name
Thomas E. Silvonek
Recipient Title
Owner
Dorneyville Pharmacy
3330 Hamilton Blvd.
Allentown
,
PA
18103-4537
United States
Issuing Office:
Office of Pharmaceutical Quality Operations, Division I
United States
Dear Mr. Silvonek:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (17-PHI-05, February 7, 2017). 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/
Stephanie Durso, Director Compliance Branch
Office of Pharmaceutical Quality Operations, Division I
Content current as of:
09/21/2020
CLOSEOUT LETTER
Dougherty's Pharmacy
MARCS-CMS 500635 —
May 14, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
2017-DAL-WL-22
Product:
Drugs
Recipient:
Recipient Name
Stewart I. Edington
Recipient Title
President/CEO
Dougherty's Pharmacy
5924 Royal Lane
Suite 250
Dallas
,
TX
75230
United States
Issuing Office:
Office of Pharmaceutical Quality Operations Division II
United States
Mr. Edington:
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 # 2017-DAL-WL-22), dated May 12, 2017. 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.
If you have any question, please do not hesitate to contact me at
John.Diehl@fda.hhs.gov
.
Sincerely,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
05/22/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Dr. Reddy's Laboratories Limited
MARCS-CMS 481160 —
August 27, 2020
Reference #:
3002949085, 3005447965, and 3006549835
Product:
Drugs
Recipient:
Recipient Name
Mr. Satish Reddy
Recipient Title
Chairman
Dr. Reddy's Laboratories Limited
8-2-337, Road No. 3
Banjara Hills, Hyderabad
530046
Andhra Pradesh
India
Issuing Office:
Division of Drug Quality I
United States
Dear Mr. Reddy:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-16-02 dated November 5, 2015. Based on our evaluation, it appears that you have addressed the violations and deviations 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 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 violations and deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Ann Plucinski
Compliance Officer
Division of Drug Quality I
Content current as of:
09/01/2020
Regulated Product(s)
Drugs