tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Moonlight Vapers
MARCS-CMS 630207 —
December 14, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200517
Product:
Tobacco
Recipient:
Recipient Name
Johnathon Boney and Katherine Gray
Moonlight Vapers
United States
Jboney17@gmail.com
grayakatherine21@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Johnathon Boney and Katherine Gray:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed evaluation of your corrective actions in response to FDA’s May 18, 2022 Warning Letter. Based on our evaluation, it appears that you have taken steps to address 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 ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act (FD&C 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.
It is your responsibility to ensure that all of your tobacco products and all related labeling and/or advertising on any websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
If you have any questions, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/s/
Chad Burger
Director
Division of Product Compliance
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
09/16/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Muscle Sports Products, LLC
MARCS-CMS 625731 —
July 26, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Jason R. Mancuso
Recipient Title
CEO
Muscle Sports Products, LLC
101 Dominion Blvd.
Ronkonkoma
,
NY
11779
United States
jmancuso@customnutra.fit
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
Dear Mr. Mancuso:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 625731, issued on September 23, 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/
Latoya A. Griffith, MPH
Director, Compliance Branch (DCB)
Office of Human and Animal Food Operations East Division 1
Content current as of:
08/01/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Mylan Laboratories Limited – Unit 7
MARCS-CMS 607508 —
February 16, 2023
Product:
Drugs
Recipient:
Recipient Name
Mr. Michael Goettler
Recipient Title
Chief Executive Officer
Mylan Laboratories Limited – Unit 7
1000 Mylan Boulevard
Canonsburg
,
PA
15317
United States
Issuing Office:
Office of Manufacturing Quality
United States
Dear Mr. Goettler:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-44 dated August 20, 2020.
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/
Joseph Lambert, Pharm.D.
Compliance Officer
Division of Drug Quality I
cc:
Mr. Jayachandra Prasad Puttagunta, Vice President of Manufacturing Services
Mylan Laboratories Limited (a Viatris Company) – Unit 7
Plot No. 14, 99&100, Phase-II; IDA, Pashamylaram, Patancheru
Sangareddy District, Telangana – 502307
India
Content current as of:
02/22/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Mylan Laboratories Limited Unit 8, a Viatris Company
MARCS-CMS 589297 —
July 27, 2023
Reference #:
FEI 3002785310
Product:
Drugs
Recipient:
Recipient Name
Mr. Scott A. Smith
Recipient Title
Chief Executive Officer
Mylan Laboratories Limited Unit 8, a Viatris Company
Viatris Inc.
1000 Mylan Boulevard
Canonsburg
,
PA
15317
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Smith:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-06 dated November 5, 2019.
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/
Tamara Rosbury, Ph.D.
Compliance Officer
Division of Drug Quality II
Content current as of:
08/01/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Myllan-ORA ehf
MARCS-CMS 637443 —
February 09, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Hermann Stefansson
Recipient Title
CEO
Myllan-ORA ehf
Vesturvor 12
200
Kopavogur
Iceland
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear: Mr. Hermann Stefansson:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 637443, issued August 30, 2022. 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/
Nick Long
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/22/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Nalpropion Pharmaceuticals LLC
MARCS-CMS 610942 —
May 10, 2023
Product:
Drugs
Recipient:
Recipient Name
Aaron Chesnut
Recipient Title
Vice President, Technical Operations
Nalpropion Pharmaceuticals LLC
155 Franklin Road
Suite 450
Brentwood
,
TN
37027
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Aaron Chesnut:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated September 22, 2020. 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 516 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. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov.
Sincerely,
{See appended electronic signature page}
Meena Savani
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/
------------------------------------------------------------
MEENA R SAVANI
05/10/2023 01:15:41 PM
Content current as of:
05/10/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
NatureLab Corp.
MARCS-CMS 625768 —
April 25, 2023
Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Charles B. Shea
Recipient Title
President
NatureLab Corp.
1606 Vantage Dr.
Carrollton
,
TX
75006-5613
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Dear Mr. Shea,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated July 12, 2022, issued following inspection of your facility located at 1606 Vantage Dr., Carrollton, TX 75006-5613. 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. If you choose to reestablish or sell your operations, 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 E. Havranek
Director of Compliance
Office of Human and Animal Food, WD3
Content current as of:
04/28/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Neitz Instruments Company Ltd.
MARCS-CMS 664336 —
October 02, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Ms. Takae Nishizawa
Recipient Title
CEO
Neitz Instruments Company Ltd.
4F Ichibancho Court 15-21
Ichibancho JP-13
Chiyoda-Ku
,
102-0082
Japan
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Ms. Nishizawa:
The United States Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 664336, dated August 25, 2023). 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/
for Malvina B. Eydelman, M.D.
Director
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
US AGENT:
Takahiro Haruyama
Globizz Corp.
1411 W. 190th St., #200
Gardena, California 90248, U.S.A.
Email: Register@Globizz.Net
Phone 1-310-538-3860
Content current as of:
02/28/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Nortec Quimica SA
MARCS-CMS 639894 —
October 23, 2023
Product:
Drugs
Recipient:
Recipient Name
Mr. Marcelo C. Mansur
Recipient Title
Chief Executive
Nortec Quimica SA
Rua Dezessete 200 - ABCD Distrito Industrial – Mantiquira
Duque de Caxias
-
RJ
25250-612
Brazil
marcelo.mansur@nortecquimica.com.br
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Mansur:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-07 dated December 8, 2022.
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/
Frank Wackes
Compliance Officer
Division of Drug Quality II
Content current as of:
10/30/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Novel Laboratories, Inc. d.b.a Lupin Somerset
MARCS-CMS 613385 —
April 14, 2023
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Ms. Vinita D. Gupta
Recipient Title
Group President-CEO
Novel Laboratories, Inc. d.b.a Lupin Somerset
B/4 Laxmi Towers
Bandra Kurla Complex, Bandra (E)
Mumbai
400051
India
vinitagupta@lupin.com
Issuing Office:
Office of Pharmaceutical Quality Operations Division I
United States
Dear Ms. Gupta:
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 # 613385], dated June 11, 2021. Based on our evaluation, it appears that you have adequately 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 a subsequent inspection or through other means.
Respectfully,
/S/
Lisa Harlan
Program Division Director
U.S. Food and Drug Administration
OPQO Division I
CC:
Mr. Ronald W. Overhiser
Vice President-Operations and Site Head
Novel Laboratories, Inc. d.b.a. Lupin
400 Campus Drive
Somerset, NJ 08873
RonaldOverhiser@lupin.com
Content current as of:
04/19/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nutra Solutions USA, Inc.
MARCS-CMS 570011 —
January 03, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Qausar Sultana
Recipient Title
Director of Quality and Co-Owner
Nutra Solutions USA, Inc.
1019 Grand Boulevard
Deer Park
,
NY
11729-5709
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Ms. Sultana:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 570011 dated September 12, 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 subsequent inspection or through other means.
Sincerely,
/S/
Lillian C. Aveta
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1
Content current as of:
01/12/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Nutra Valley LLC
MARCS-CMS 627030 —
February 09, 2023
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
William Wallace
Recipient Title
Director of Quality
Nutra Valley LLC
Muscle Feast, LLC
1320 Boston Rd
Nashport
,
OH
43830-9603
United States
wwallace@nutravalley.com
Issuing Office:
Office of Human and Animal Foods – East 5
United States
Dear Dr. Wallace:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 627030 issued on July 22, 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/
Stephen J. Rabe
Compliance Officer
Content current as of:
02/10/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Omega Engineering Inc.
MARCS-CMS 613560 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Christine Riggs
Recipient Title
In-House Counsel
Omega Engineering Inc.
800 Connecticut Avenue
Suite 5N01
Norwalk
,
CT
06854
United States
criggs@omega.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Christine Riggs:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613560, dated March 4, 2021). 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 in the future.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director 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:
07/27/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Omnisense Systems Pte Ltd
MARCS-CMS 613561 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Leonard Lim
Omnisense Systems Pte Ltd
8 Penjuru Lane
609189
Singapore
enquiries@omnisense-systems.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Leonard Lim:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #613561, dated March 4, 2021). 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 in the future.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director
Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Andrew Southern
Invisible Health Technologies
520 West 27th St.Suite 407
New York, NY 10001
andrew@invisiblehealthtechnologies.com
Andrew Southern
Invisible Health Technologies
3250 NE 1st Ave, Suite 305
Miami, FL 33137
andrew@invisiblehealthtechnologies.com
Adam Lim
Native Instinct LLC
3206 Canal Drive,
Boynton Beach, FL 33435
adam@nativeinstinct.co
Content current as of:
07/24/2023
Regulated Product(s)
Medical Devices