tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
AstraZeneca Pharmaceuticals LP
MARCS-CMS 664789 —
May 29, 2024
Reference #:
NDA 212122
Product:
Drugs
Recipient:
Recipient Name
Inna Kissen, Ph.D.
Recipient Title
Senior Director, Promotional Regulatory Affairs
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Wilmington
,
DE
19850
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Secondary Issuing Offices
United States
Dear Dr. Kissen:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated August 4, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance 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 surveillance or through other means.
If you have any questions or comments, please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 385 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Additionally, the response submission should be coded as an Amendment to eCTD Sequence 0560 under NDA 212122. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDPRPM@fda.hhs.gov.
Sincerely,
{See appended electronic signature page}
Kyle Snyder, PharmD
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
--------------------------------------------------------------------------------------------
/s/
------------------------------------------------------------
KYLE SNYDER
05/29/2024 09:53:15 AM
Content current as of:
05/31/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Atlantic Bakery Ltd. d.b.a. Old School Bakery
MARCS-CMS 580244 —
March 22, 2024
Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-04
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. William B. Himmelrich
Recipient Title
Owner
Atlantic Bakery Ltd. d.b.a. Old School Bakery
45 North Congress
Delray Beach
,
FL
33445
United States
billybake@msn.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Secondary Issuing Offices
United States
Dear Mr. Himmelrich:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 19-HAFE4-WL-08 dated July 12, 2019. 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/
Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
04/03/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
A&Z Pharmaceutical Inc
MARCS-CMS 645101 —
May 24, 2024
Product:
Dietary Supplements
Recipient:
Recipient Name
Emma Qingbo Li Xu
Recipient Title
Chairwoman/CEO
A&Z Pharmaceutical Inc
180 Oser Ave., Suite 300
Hauppauge
,
NY
11788-3709
United States
emmaerwin@azpharmaceutical.com
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Secondary Issuing Offices
United States
Dear Ms. Li Xu:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 645101, issued on June 1, 2023. 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/
Lillian C. Aveta
Acting Director, Compliance Branch (ADCB)
Office of Human and Animal Food Operations East Division 1
Content current as of:
05/30/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Bakkavor Foods USA Inc.
MARCS-CMS 630545 —
February 15, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Kamran Lodi
Recipient Title
Chief Operating Officer
Bakkavor Foods USA Inc.
2700 Westinghouse Blvd
Charlotte
,
NC
28273
United States
Issuing Office:
Office of Human and Animal Food Operations – East Division 3
United States
Secondary Issuing Offices
United States
Dear Mr. Lodi:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, CMS# 630545 dated August 8, 2022. 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/
Victoria L. Palmer
Compliance Officer
Office of Human and Animal Foods, East Division
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
02/20/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Barkey GmbH & Co. KG
MARCS-CMS 657073 —
July 30, 2024
Delivery Method:
Via UPS and EMAIL
Product:
Biologics
Recipient:
Recipient Name
Christian Barkey/Thomas Barkey
Recipient Title
Chief Executive Officer/Managing Director
Barkey GmbH & Co. KG
Gewerbestr. 8
North Rhine-Westphalia
33818
Leopoldshohe
Germany
thomas.barkey@barkey.de
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Mr. Christian Barkey and Mr. Thomas Barkey:
The United States Food and Drug Administration (FDA) has reviewed your firm’s corrective actions in response
1
to our Warning Letter issued to you on January 31, 2024. Based on our evaluation, it appears that you have addressed the violation(s) detailed in the Warning Letter.
2
Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of your corrective actions.
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, its implementing regulations, or 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/
Melissa Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Cc: Robert Woodward
Managing Director
Azenta Inc.
15 Elizabeth Drive
Chelmsford, MA 01824
rob.woodward@azenta.com
1
Your corrective actions are detailed in correspondences dated February 23, 2024, April 5, 2024, May 14, 2024, May 29, 2024, and July 5, 2024.
2
Your response indicates that you have ceased distribution of the plasmatherm V in the U.S. Additionally, you have initiated a recall of the device from U.S. customers. We expect you to see this through to completion.
Content current as of:
08/05/2024
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Barsotti Juice Company, Inc.
MARCS-CMS 676447 —
September 17, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Michael N. Barsotti
Recipient Title
President
Barsotti Juice Company, Inc.
2239 Hidden Valley Lane
Camino
,
CA
95709
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
Secondary Issuing Offices
United States
Dear Mr. Barsotti:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 676447 dated January 30, 2024. 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/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Content current as of:
09/23/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Biorica International Corp.
MARCS-CMS 659194 —
April 09, 2024
Product:
Dietary Supplements
Recipient:
Recipient Name
Jacqueline Baxas
Recipient Title
President
Biorica International Corp.
4310 Sheridan St., Suite 202
Hollywood
,
FL
33021
United States
info@biorica.biz
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear Ms. Baxas:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #659194, issued August 4, 2023. 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
04/17/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Boehringer Ingelheim Animal Health USA
MARCS-CMS 674535 —
September 25, 2024
Product:
Animal & Veterinary
Recipient:
Recipient Name
Randolph Legg
Recipient Title
President and Head of Commercial Business
Boehringer Ingelheim Animal Health USA
3239 Satellite Blvd
Duluth
,
GA
30096
United States
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
Dear Mr. Legg:
The Food and Drug Administration has completed evaluation of your firm’s response to our Warning Letter dated March 1, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.
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 surveillance or through other means.
If you have any questions or comments, please contact Dr. Christopher Loss at christopher.loss@fda.hhs.gov. If you wish to send a response, please direct your response to the undersigned at the Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Pharmacovigilance and Surveillance, 12225 Wilkins Ave, MPN II Room E474, Rockville, Maryland 20852. Please send a courtesy copy by email to CVMSurveillance@fda.hhs.gov. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter # 674535.
Sincerely,
/S/
Linda Walter-Grimm, DVM
Director, Division of Pharmacovigilance and Surveillance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Content current as of:
10/02/2024
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Certify Global Inc.
MARCS-CMS 613568 —
December 13, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Marc Potash
Certify Global Inc.
9801 Washingtonian Boulevard
Suite 200
Gaithersburg
,
MD
20878
United States
marc.potash@certifyglobal.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Marc Potash:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613568, dated March 4, 2021. 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/
Kellie B. Kelm, Ph.D.
Acting Office Director
OHT 3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
12/17/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Dairy Feeds, Inc.
MARCS-CMS 625951 —
July 08, 2024
Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-07
Product:
Animal & Veterinary
Recipient:
Recipient Name
Ms. Brenda Godwin
Recipient Title
General Manager
Dairy Feeds, Inc.
P.O. Box 1365
Okeechobee
,
FL
34973-1365
United States
dairyfeeds@embarqmail.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Secondary Issuing Offices
United States
Dear Ms. Brenda Godwin:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 22-HAFE4-WL-06, dated July 27, 2022. 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/
Pearl E. Lopina -S
Pearl Lopina
Director of Compliance Branch
Content current as of:
07/17/2024
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Dalian Lingfa Food Co., Ltd.
MARCS-CMS 681016 —
September 23, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ping Ling Huang
Recipient Title
Owner
Dalian Lingfa Food Co., Ltd.
Dengshahe Town
Jinzhou Qu
Dalian Shi
Liaoning Sheng
,
116105
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear Huang,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #681016, issued June 3, 2024. 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 Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
09/27/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Day Light Nutrition
MARCS-CMS 653234 —
May 31, 2024
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Alvin Morrow
Recipient Title
Owner
Day Light Nutrition
8565 Airport Rd
St Louis
,
MO
63134
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Secondary Issuing Offices
United States
Dear Mr. Morrow:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 653234) on August 4, 2023. 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director,
Office of Human and Animal Food-West Div. 2
Content current as of:
06/07/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Desserts by Helen, Inc.
MARCS-CMS 659181 —
March 15, 2024
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Craig A. Friedman
Recipient Title
Vice President
Desserts by Helen, Inc.
283 Thompson Avenue
Louisville
,
KY
40206-1071
United States
craig@dessertsbyhelen.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Secondary Issuing Offices
United States
Dear Mr. Friedman:
The Food and Drug Administration has completed evaluation of Dessert by Helen Inc. corrective actions in response to our Warning Letter 659181, dated September 11, 2023. Based on our evaluation, it appeared 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/
Allison C. Hunter
Compliance Officer
Office of Human & Animal Foods Operations
East 5 Division
Content current as of:
03/18/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Drive DeVilbiss Healthcare LLC
MARCS-CMS 619182 —
October 23, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Derek Lampert
Recipient Title
Chief Executive Officer (CEO)
Drive DeVilbiss Healthcare LLC
99 Seaview Blvd, Suite 210
Port Washington
,
NY
11050
United States
Issuing Office:
Office of Medical Device and Radiological Health Operations (Division 1)
United States
Secondary Issuing Offices
United States
Dear Mr. Lampert:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 619182, dated November 23, 2021. 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/
RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
10/30/2024
Regulated Product(s)
Medical Devices