tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Ruben's Inc.
MARCS-CMS 568410 —
August 01, 2019
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
David Garcia
Recipient Title
President
Ruben's Inc.
401 Maple St. NE
Albuquerque,
,
NM
87106
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
6th Ave & Kipling Street
P.O. Box 25087
Denver
,
CO
80225
United States
Dear Mr. Garcia:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W-19-02-WL-DR dated November 6, 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food Operations
Division IV West
Content current as of:
08/05/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
RX South DBA RX3 Compounding Pharmacy LLC
MARCS-CMS 440735 —
June 26, 2019
Product:
Drugs
Recipient:
Recipient Name
Christopher K. Currin, R.Ph.
Recipient Title
Co-Owner
RX South DBA RX3 Compounding Pharmacy LLC
12230 Iron Bridge Rd.
Suite C
Chester
,
VA
23831-1534
United States
Issuing Office:
Center for Drug Evaluation and Research
10 Waterview Blvd.
3rd FL
Parsippany
,
NJ
07054
United States
(973) 331-4900
Dear Mr. Currin:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated October 23, 2014. 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/
Craig Swanson
Acting Program Division Director/District Director
Office of Manufacturing Quality Operations
Division I/New Jersey District
Content current as of:
07/02/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
A-S Medication Solutions LLC.
MARCS-CMS 522197 —
February 25, 2019
Recipient:
Recipient Name
Walter Hoff
A-S Medication Solutions LLC.
A-S Medication Solutions LLC.
2401 Commerce Drive
Libertyville
,
IL
60048
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Mr. Hoff,
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter, dated June 5, 2017. Based on our evaluation, it appears that you have addressed the major violations described in the warning letter for drug products that fall under labeler code 50090. As such, please consider this letter to be a close out of the warning letter.
Although we are issuing this close out, we still expect A-S Medication Solutions (ASM), to continue working on and improving its drug listing files to ensure that complete and accurate drug listing data is submitted to the FDA as required by law. In a final random review of your recent submissions, some minor listing issues were found, which we expect will be addressed by your firm through future corrective efforts. FDA is also aware of several pending submissions which might need further corrections or manual overrides; these potential issues will be evaluated and finalized on a case by case basis.
Please be aware that corrective actions for drug products listed under labeler code 54569 remain unaddressed. As part of the discussions between FDA and ASM, ASM agreed to delist all drug products listed under labeler code 54569, but to date, no SPLs have been submitted to FDA with end marketing dates for those listings. Future FDA regulatory activities will further assess the adequacy and sustainability of the corrections already made and your firm's pending and future submissions.
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 to 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/
Paul M. Loebach
Director, Drug Registration and Listing Staff
WO51, Rm2262 10903 New Hampshire Ave
Silver Spring, MD 20993
paul.loebach@fda.hhs.gov
Content current as of:
03/11/2019
CLOSEOUT LETTER
Sage Products Inc
MARCS-CMS 520382 —
September 05, 2019
Delivery Method:
UPS Next Day
Signature Required
Product:
Drugs
Recipient:
Recipient Name
Kevin A. Lobo
Recipient Title
Chairman & CEO
Sage Products Inc
Stryker Corporation
2825 Airview Boulevard
Kalamazoo
,
MI
49002
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III (PHRM3)
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Lobo:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of Sage Products, Inc.’s corrective actions in response to our warning letter [Case #520382, July 17, 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 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
cc: Mr. Donald E. Payerle
Vice President and General Manager
Sage Products, Inc.
3909 Three Oaks Road
Cary, IL 60013
Content current as of:
09/10/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sami's Pita Bakery, Inc.
MARCS-CMS 497911 —
February 15, 2019
Recipient:
Recipient Name
Sami (NMI) Chehab
Recipient Title
President
Sami's Pita Bakery, Inc.
2399 E. Busch Blvd.
Tampa
,
FL
33612-8407
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
(787) 729-8500
Dear Mr. Chehab:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter FLA-17-01, dated October 26, 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 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
OHAFO, Division IV East
Content current as of:
03/08/2019
CLOSEOUT LETTER
Samuel Zimmerman
MARCS-CMS 553340 —
June 25, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Samuel Zimmerman
Samuel Zimmerman
1853 Himrod Road
Penn Yan
,
NY
14527-8744
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Zimmerman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 553340 dated September 5, 2018 issued to your farm. 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 farm 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 farm 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 M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1
Content current as of:
07/02/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
San Diego Compounding Pharmacy
MARCS-CMS 520259 —
July 08, 2019
Delivery Method:
VIA UPS
SIGNATURE CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Jerome A. Greene
Recipient Title
Owner/Pharmacist
San Diego Compounding Pharmacy
5395 Ruffin Road
Suite 104
San Diego
,
CA
92123-1338
United States
Issuing Office:
Center for Drug Evaluation and Research
19701 Fairchild Road
Irvine
,
CA
92612-2506
United States
949-608-2900
Dear Mr. Greene:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [CMS# 520259, September 25, 2017]. 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 assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Steven E. Porter Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
07/12/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Seedling Enterprise, LLC
MARCS-CMS 484628 —
February 14, 2019
Recipient:
Recipient Name
Peter Klein
Recipient Title
Owner
Seedling Enterprise, LLC
6717 111th Ave
South Haven
,
MI
49090
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Klein,
The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 2016-DET-11, dated May 19, 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/
Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Division East 6
Content current as of:
03/08/2019
WARNING LETTER
Shanghai Institute of Pharmaceutical Industry
MARCS-CMS 574821 —
August 29, 2019
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Ms. Hongjuan Pan
Recipient Title
Testing Laboratory Director
Shanghai Institute of Pharmaceutical Industry
No. 285 Gebaini Road
Pudong District
Shanghai Shi
,
201203
China
Issuing Office:
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Warning Letter
320-19-40
August 29, 2019
Dear Ms. Pan:
The U.S. Food and Drug Administration (FDA) notified your site
,
Shanghai
Institute
of
Pharmaceutical
Industry
at
No. 285 Gebaini Road, Pudong District, Shanghai,
of a planned surveillance and pre-approval inspection of your drug
product testing facility from November 29 to December 4, 2018. Your firm refused the pre-announced inspection in a written response to the FDA China Office on December 4, 2018.
Your firm is listed as a contract testing laboratory that provides active pharmaceutical ingredient (API) characterization and/or identification testing to support multiple abbreviated new drug applications (ANDAs).
Under section 501(j) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), drugs are deemed adulterated if they are manufactured, processed, packed, or held in an establishment
and the owner, operator, or agent delays, denies, limits, or refuses an inspection.
See FDA’s guidance document,
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,
at
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf
.
Until FDA is permitted to inspect your facility and confirms compliance with current good manufacturing practice (CGMP), this office may recommend withholding approval of any new applications or supplements listing your firm as a drug manufacturer.
After you receive this letter, respond to this office in writing within 15 working days.
Send your electronic reply to
CDER-OC-OMQ-Communications@fda.hhs.gov
or mail your reply to:
Carrie Ann Plucinski
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
Please identify your response with FEI 3002808132.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
10/01/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Shenzhen Creative Industry Co., Ltd.
MARCS-CMS 484188 —
May 08, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Wang Jia
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3
Nanyou Tianan
Shenzhen Shi
Guangdong Sheng
,
518054
China
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Ms. Wang Jia:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated 01/15/2016 and the inspection conducted on 11/05-08/2018. 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.
Sincerely,
/S/
Bram Zuckerman
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
05/14/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Sherwood Food Distributors, LLC
MARCS-CMS 444136 —
February 14, 2019
Recipient:
Recipient Name
Marc A. Siegler
Sherwood Food Distributors, LLC
12499 Evergreen Road
Detroit
,
MI
48228
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
550 W. Jackson Blvd.
Suite 1500
Chicago
,
IL
60661
United States
Dear Mr. Siegler,
The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 2015-DET-02, dated November 19, 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/
Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Division East 6
Content current as of:
03/04/2019
CLOSEOUT LETTER
SI Marketing Inc.
MARCS-CMS 521356 —
April 15, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Peter D.J. Kim
Recipient Title
President
SI Marketing Inc.
905 Keeaumoku Street
Suite 102
Honolulu
,
HI
96814-2300
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
510-337-6700
Dear Mr. Kim:
The Food and Drug Administration has completed an evaluation of SI Marketing Inc. corrective actions in response to our Warning Letter 521356 dated April 4, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
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
Sinu Co., Ltd
MARCS-CMS 585410 —
October 21, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Dong Min Lee
Recipient Title
President
Sinu Co., Ltd
B-501, 1
Wonyang-ro
Seo-gu
Busan
49277
South Korea
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Lee:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 585410, issued July 24, 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
SNAC System Inc.
MARCS-CMS 509443 —
April 04, 2019
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Victor (NMI) Conte
Recipient Title
CEO
SNAC System Inc.
100 Industrial Road
Suite 12
San Carlos
,
CA
94070
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. Victor Conte:
The Food and Drug Administration has completed an evaluation of SNAC System, Inc. corrective actions in response to our Warning Letter 509443 dated February 27, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Solomon Snacks and Bakery, LLC
MARCS-CMS 480895 —
May 23, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Veronica Anczarski
Recipient Title
Co-owner/Manager
Solomon Snacks and Bakery, LLC
833 Third Street SW
New Brighton
,
MN
55112
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
(612) 334-4100
Dear Ms. Anczarski:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter MIN 16-05 dated January 5, 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/
Dianna C. Sonnenburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
06/05/2019
Regulated Product(s)
Food & Beverages