tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
ARJ Infusion Services Inc
MARCS-CMS 548673 —
March 06, 2019
Delivery Method:
UPS
Recipient:
Recipient Name
Mary L. Sackuvich
Recipient Title
President and Owner
ARJ Infusion Services Inc
ARJ Infusion Services Inc
7930 Marshall Drive
Lenexa
,
KS
66214
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Ms. Sackuvich:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: Case# 548673) dated April 2, 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 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
Content current as of:
03/12/2019
CLOSEOUT LETTER
Banjaras Inc
MARCS-CMS 589115 —
March 24, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Sumit Kaur
Recipient Title
President
Banjaras Inc
2707 Gallion Dr.
Sugar Land
,
TX
77479-1979
United States
Issuing Office:
Division of Southwest Imports
United States
Dear Ms. Kaur,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter Ref: CMS 589115 dated September 25, 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/
Rosa Linda Santos
Compliance Officer
Content current as of:
02/12/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Battle Creek Equipment Co.
MARCS-CMS 455012 —
July 09, 2019
Delivery Method:
VIA UPS
Reference #:
2015-DET-09
Product:
Medical Devices
Recipient:
Recipient Name
David Underhill
Recipient Title
President
Battle Creek Equipment Co.
702 S. Reed Road
Fremont
,
IN
46767-2098
United States
Issuing Office:
Center for Device and Radiological Health
One Montvale Avenue
Stoneham
,
MA
02180
United States
Dear Mr. Underhill:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 2015-DET-09 (CMS Case 455012), issued on April 3, 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 yours,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
07/09/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Becton Dickinson Medical Systems
MARCS-CMS 563754 —
February 11, 2019
Recipient:
Recipient Name
Vincent Forlenza
Recipient Title
Chairman & CEO
Becton Dickinson Medical Systems
Becton Dickinson Medical Systems
1 Becton Drive
Franklin Lakes
,
NJ
07417
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Forlenza:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 563754 dated September 14, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. We acknowledge the closure of the Becton Dickinson (BD) Medical Systems facility located at 9630 S. 54th St., Franklin, WI. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of your 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
CC: Kurt Ebenhoe, Director of Quality Management
kurt_ebenhoe@bd.com
Boris Shkolnik, Jones, WW Vice President Quality Management
boris_shkolnik@bd.com
Content current as of:
03/04/2019
CLOSEOUT LETTER
Berkeley Nutritional Manufacturing Corporation dba Protein Research
MARCS-CMS 500324 —
February 21, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Robert W. Matheson
Recipient Title
President
Berkeley Nutritional Manufacturing Corporation dba Protein Research
1852 Rutan Drive
Livermore
,
CA
94551
United States
Issuing Office:
Division of Human and Animal Food -West 5
United States
Dear Mr. Robert W. Matheson:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 500324, dated January 31, 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, Director of Compliance
Office Human and Animal Foods
Division of Human and Animal Food-West 5
Content current as of:
05/07/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Bestway Sandwiches, Inc.
MARCS-CMS 469811 —
March 05, 2019
Delivery Method:
United Parcel Service
Reference #:
WL #22-15
Recipient:
Recipient Name
Khachatur C. Budagyan, Jack Khandzyan
Recipient Title
Co-Owner
Bestway Sandwiches, Inc.
Bestway Sandwiches, Inc.
1530 1st St
San Fernando
,
CA
91340-2708
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Messrs. Budagyan and Khandzyan:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #22-15 dated June 18, 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,
/S/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
03/12/2019
CLOSEOUT LETTER
Bharat Bazar, Inc.
MARCS-CMS 472826 —
February 21, 2019
Delivery Method:
USPS
Recipient:
Recipient Name
Veena Birla
Recipient Title
Vice President/Secretary
Bharat Bazar, Inc.
Bharat Bazar, Inc.
34301 Alvarado Niles Rd.
Union City
,
CA
94587-4455
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Birla:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated July 13, 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/
Sergio Chavez
Director Compliance Branch
Food and Drug Administration
HAF Division West 5
Content current as of:
03/08/2019
CLOSEOUT LETTER
Blue Pacifico S.A.C.
MARCS-CMS 501228 —
June 05, 2019
Delivery Method:
Via Email
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Byeong Joon Nam
Recipient Title
President
Blue Pacifico S.A.C.
Av. General Garzon 1283
Oficina 609, Jesus Maria
Lima
23001
Tacna
Peru
tacnaof@bluepacifico-peru.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Nam:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 501228, issued August 26, 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/
Maria Corpuz, Team Lead
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/10/2019
Regulated Product(s)
Food & Beverages
Seafood/Seafood Product
CLOSEOUT LETTER
Buderer Drug Company Inc
MARCS-CMS 506509 —
May 01, 2019
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
James W. Buderer
Recipient Title
President
Buderer Drug Company Inc
26611 Dixie Hwy
Ste 119
Perrysburg
,
OH
43551-1765
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
(313) 393-8100
Dear Mr. Buderer:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CIN-16-506509-22), dated September 20, 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
05/08/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Calwood Nutritionals, LLC.
MARCS-CMS 482185 —
July 30, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Gary J. Calton
Recipient Title
Managing Member
Calwood Nutritionals, LLC.
1228 Hay Meadow Ln.
Sykesville
,
MD
21784-5438
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
6000 Metro Drive
Suite 101
Baltimore
,
MD
21215
United States
410- 779-5455
Dear Mr. Calton,
On December 12, 2018, The Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#482185), dated February 2, 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/
CDR Rochelle B. Young, RPh, MSA
Human and Animal Food Division 2 East
Compliance Officer
Content current as of:
08/01/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Casa Pablo's Salsa LLC
MARCS-CMS 562159 —
August 02, 2019
Delivery Method:
Overnight Delivery
Signature Required
Product:
Food & Beverages
Recipient:
Recipient Name
Dominic Alonzo and Robert Powell
Recipient Title
Managing Members
Casa Pablo's Salsa LLC
938 Phillips Street #3
Missoula
,
MT
59802-2624
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
22215 26th Avenue SE
Suite 210
Bothell
,
WA
98021
United States
Dear Messrs. Alonzo and Powell:
The Food and Drug Administration has completed an evaluation of your firm's oorrective actions in response to our Warning Letter CMS 562159 dated October 16, 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/
Miriam R. Burbach
District Director
Program Division Director
Office of Human and Animal Foods
Division West VI
cc: Montana Department of Public
Health and Human Services
Cogswell Building
P.O. Box 202951
Helena, Montana 59620-2951
Gaylord S. Barnhill, Supervisor
Casa Pablo's Salsa, LLC
938 Phillips Street tr.3
Missoula, Montana 59802-2624
Content current as of:
08/05/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Christoferson Meat Company Inc. dba Raws for Paws LLC
MARCS-CMS 555466 —
June 11, 2019
Delivery Method:
Overnight Delivery
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mark G. Mann
Recipient Title
Owner
Christoferson Meat Company Inc. dba Raws for Paws LLC
2700 26th Avenue South
Minneapolis
,
MN
55406
United States
Issuing Office:
Division of Compliance
7519 Standish Place
Rockville
,
MD
20855
United States
Dear Mr. Mann:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated October 25, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter by discontinuing the manufacturing and distribution of raw pet food. 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 actions should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Eric M. Nelson
Director, Division of Compliance
Center for Veterinary Medicine
Content current as of:
05/21/2020
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Civic Center Pharmacy Inc.
MARCS-CMS 453724 —
April 02, 2019
Delivery Method:
SIGNATURE CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Tenille D. Davis
Recipient Title
Pharmacist In Charge
Civic Center Pharmacy Inc.
7331 E. Osborn Drive
Suite 208
Scottsdale
,
AZ
85251-6420
United States
Issuing Office:
Center for Drug Evaluation and Research
19701 Fairchild
Irvine
,
CA
92612-2506
United States
949-608-2900
Dear Dr. Davis:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #32-15 dated August 20, 2015. 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:
08/14/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Concord, Inc. dba Carlton's Dunwoody Pharmacy
MARCS-CMS 512043 —
November 18, 2019
Product:
Drugs
Recipient:
Recipient Name
Marvin O. McCord
Recipient Title
Owner
Concord, Inc. dba Carlton's Dunwoody Pharmacy
5484 Chamblee Dunwoody Road
Suite B19
Dunwoody
,
GA
30338-4133
United States
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Mr. McCord:
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 # 512043], dated August 20, 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 ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
John Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Cc: Tanja Battle, Executive Director
Georgia State Board of Pharmacy (cover letter only)
2 Peachtree Street NW, 6th Floor
Atlanta, GA 30303
Content current as of:
11/27/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Creative Science, Inc.
MARCS-CMS 554119 —
October 08, 2019
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Bradley H. Butler
Recipient Title
President/CEO
Creative Science, Inc.
455 Sovereign Ct.
Ballwin
,
MO
63011
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Butler:
We received your July 3, 2018, and August 16, 2018, letters and August 22, 2019, and September 6, 2019, email communications in response to Warning Letter Case# 554119. Your letters and email communications have been made a part of the Food and Drug Administration’s (FDA) permanent file for your firm.
The FDA has completed an evaluation of your corrective actions in response to the warning letter. Based on our evaluation, it appears that 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 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 be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
11/01/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Curasan AG, Frankfurt Facility
MARCS-CMS 534581 —
June 03, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Michael Schlenk
Recipient Title
Chief Executive Officer
Curasan AG, Frankfurt Facility
Lindigstrse 4
63801
Kleinostheim
Germany
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Schlenk:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #534581, dated August 23, 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/
Keisha R. Thomas, MS, MHS, RAC
Deputy Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health
CC:
Ray Shane
3200 Chapel Hill-Nelson Blvd.
Suite 201
Research Triangle Park, NC 27709
Content current as of:
05/24/2022
Regulated Product(s)
Medical Devices