tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Magnolia Medical Technologies, Inc.
MARCS-CMS 617922 —
May 04, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Gregory J. Bullington
Recipient Title
CEO
Magnolia Medical Technologies, Inc.
200 W. Mercer St
Suite 500
Seattle
,
WA
98119
United States
Greg.bullington@magnolia-medical.com
Issuing Office:
Office of Medical Devices and Radiological Health, Division 3
United States
Dear Mr. Bullington:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated September 17, 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/
Jessica Mu
Director, Compliance Branch
Office of Medical Devices and Radiological Health, Division III
Content current as of:
05/18/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Malanda, Inc. dba Mandell's Clinical Pharmacy
MARCS-CMS 608320 —
November 09, 2022
Product:
Drugs
Recipient:
Recipient Name
Teresa Malanda, R.Ph.
Recipient Title
Pharmacist/Owner
Malanda, Inc. dba Mandell's Clinical Pharmacy
7 Cedar Grove Lane
Somerset
,
NJ
08873-1331
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Dear Ms. Malanda:
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: WL# 608320) dated June 9, 2020. 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/
Nerizza Guerin
Acting Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I
Content current as of:
11/21/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Maple Rose Enterprises, Inc, dba Pencol Pharmacy
MARCS-CMS 520095 —
March 10, 2022
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Mr. Tony E. Jones
Recipient Title
Owner
Maple Rose Enterprises, Inc, dba Pencol Pharmacy
1325 S. Colorado Blvd
Suite B-024
Denver
,
CO
80222
United States
Issuing Office:
Los Angeles District Office
United States
Dear Mr. Jones:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (Ref CMS 520095) dated August 2, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Lance M. De Souza
Acting Director, Pharmaceutical Quality Operations IV
Content current as of:
03/14/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Martinez Produce & Seafood Inc
MARCS-CMS 613516 —
March 04, 2022
Delivery Method:
Via Email
Reference #:
FY21-HAFE6-WL-02
Product:
Food & Beverages
Recipient:
Recipient Name
Teodoro Martinez
Recipient Title
CEO/Owner
Martinez Produce & Seafood Inc
340 North Sacramento Boulevard
Chicago
,
IL
60612
United States
ted@mpseafood.com
Issuing Office:
Office of Human and Animal Food Operations East Division VI
United States
Dear Mr. Martinez:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY21-HAFE6-WL-02 dated April 28, 2021. 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/
Lauren E. Sexton
Compliance Officer
Office of Human and Animal Food Operations
Division East 6
Content current as of:
03/14/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Merete Medical GmbH
MARCS-CMS 571091 —
July 05, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Alexia Anapliotis
Recipient Title
CEO
Merete Medical GmbH
Alt-Lankwitz 102
12247
Berlin
Germany
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Alexia Anapliotis:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 571091, dated December 31, 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC US Agent:
Marc Kneissler
One Lincoln Centre
18W140 Butterfield Road, 15th Floor
Oakbrook Terrace, IL US 60181
Email: Mkneissler@Merete-Medical.Com
Content current as of:
07/05/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Metamune Inc
MARCS-CMS 614543 —
March 15, 2022
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Satyen Chatterjee
Metamune Inc
8001 S 194th ST.
Kent
,
WA
98032
United States
www.bodymune.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Chatterjee:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614543, issued September 7, 2021. 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:
03/15/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
MKS Enterprise LLC
MARCS-CMS 624478 —
September 02, 2022
Product:
Dietary Supplements
Recipient:
Recipient Name
Satish Bhatia
MKS Enterprise LLC
59 Paulison Ave. #13
Passaic
,
NJ
07055
United States
mks@wholesaleonline1.com
sam77usa@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Mr. Bhatia,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #624478, issued July 1, 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/
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:
02/13/2026
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Mystic Juice USA LLC
MARCS-CMS 617032 —
June 16, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101629
Product:
Tobacco
Recipient:
Recipient Name
Christopher Schmitz
Mystic Juice USA LLC
United States
mysticjuiceusa@gmail.com
sales@mysticjuiceusa.com
chris@mysticjuiceusa.com
Issuing Office:
Center for Tobacco Products
United States
Dear Christopher Schmitz:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated August 20, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.mysticjuiceusa.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation 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 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Customer Privacy Inc. Customer 0137515529
mysticjuiceusa.com@contactprivacy.com
Shopify, Inc.
abuse@shopify.com
Tucows, Inc.
domainause@tucows.com
Content current as of:
06/24/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Namsa
MARCS-CMS 544884 —
October 07, 2022
Product:
Biologics
Recipient:
Recipient Name
Pinaki Chakraborty, MS, Ph.D., MBA
Recipient Title
Vice President, Global Quality and Regulatory Compliance
Namsa
400 Highway 169
Suite 500
Minneapolis
,
MN
55426
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Dr. Chakraborty:
The FDA has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated March 23, 2018, and the follow up inspection conducted on August 30, 2021, to September 21,2021. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in the WL and in the one item FDA Form-483, dated September 21, 2021, and has implemented the corrective actions, as promised in your response letters, dated October 11, 2021, December 31, 2021, April 3, 2022, and July 7, 2022.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Sheena Green, MS
Assistant Director
DCEA1: Division of Clinical Policy and Quality
OCEA: Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
11/08/2022
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Natural Sprout Co LLC
MARCS-CMS 610151 —
September 02, 2022
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Stephen F. Aton
Recipient Title
Member
Natural Sprout Co LLC
1571 E. Cherokee Street
Springfield
,
MO
65804
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Dear Mr. Aton,
The Food and Drug Administration has completed an evaluation of Natural Sprout Co LLC corrective actions in response to our Warning Letter (CMS case #610151) on October 29, 2020. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
District Director
FDA Kansas City District
Program Division Director
Office Of Human and Animal Foods-West Division 2
Content current as of:
09/06/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Olympus Medical Systems Corporation
MARCS-CMS 546986 —
April 04, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Julien Sauvagnargues
Recipient Title
President & CEO
Olympus Medical Systems Corporation
3500 Corporate Parkway
Center Valley
,
PA
18034
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Julien Sauvagnargues:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546986, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) 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.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Center for Devices and Radiological Health
CC:
Laura Storms
Vice President, Regulatory Affairs & Quality Assurance
Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley, Pennsylvania 18034
Kota Nozue
Postmarket Surveillance Project Leader
3500 Corporate Parkway P.O. Box 610
Center Valley, Pennsylvania 18034
Akihiro Okubo, President
Olympus Medical Systems Corporation
2951 Ishikawa-cho, Hachioji-shi
Tokyo 192-8507, Japan
Content current as of:
04/08/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Orphic Nutrition
MARCS-CMS 612470 —
October 19, 2022
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Philipp Triebel
Recipient Title
Managing Director
Orphic Nutrition
2443 Fillmore St, #380-7475
San Francisco
,
CA
94115
United States
Issuing Office:
Office of Human and Animal Food Operations –West Division 5
United States
Dear Mr. Triebel:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 612470 dated April 13, 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/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
CC: Ms. Barbara Radon, Head of Regulatory & Compliance
SellerX
Jägerstr. 41
Berlin 10117, Germany
barbara.radon@sellerx.com
Content current as of:
10/24/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Panther James LLC. dba Drought
MARCS-CMS 610082 —
November 16, 2022
Delivery Method:
VIA EMAIL WITH READ RECEIPT
Reference #:
FY21-HAFE6-WL-01
Product:
Food & Beverages
Recipient:
Recipient Name
Caitlin G. James
Recipient Title
CEO
Panther James LLC. dba Drought
44696 Morley Dr.
Clinton Township
,
MI
48036
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Caitlin G. James, CEO
Jennifer E. James, COO
Jessica M. James, Chief Business Development Officer
Julie James, Chief Marketing Officer
Dear Mss. James,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (FY21-HAFE6-WL-01, issued March 5, 2021). 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/
Kelli Wilkinson
Director of Compliance
Office of Human and Animal Food
Division East 6
Content current as of:
11/18/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
PBDragon LLC
MARCS-CMS 626854 —
June 10, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201738
Product:
Tobacco
Recipient:
PBDragon LLC
Jeremy Harris
United States
info@pbdragon.com
pb@pbdragon.com
vaportoolbar@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Jeremy Harris:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated February 11, 2022. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://pbdragon.com/store.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation 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 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Launchpad.com, Inc.
abuse@hostgator.com
Unified Layer
abuse@bluehost.com
Content current as of:
06/22/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Peggy Lawton Kitchens, Inc.
MARCS-CMS 586321 —
November 01, 2022
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. William H. Wolf
Recipient Title
President and Owner
Peggy Lawton Kitchens, Inc.
255 Washington Street
East Walpole
,
MA
02032-1133
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Wolf:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 586321 dated August 29, 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/
Latoya A. Griffith
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1
Content current as of:
11/08/2022
Regulated Product(s)
Food & Beverages