tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
1st Phorm LLC
MARCS-CMS 613715 —
February 08, 2022
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Andrew Frisella
Recipient Title
CEO
1st Phorm LLC
2091 Fenton Logistics Park Blvd
Fenton
,
MO
63026
United States
Issuing Office:
Office of Human and Animal Food West Division II
United States
Dear Mr. Andrew Frisella,
The Food and Drug Administration has completed an evaluation of 1st Phorm LLC corrective actions in response to our Warning Letter (CMS case #: 613715) on July 29, 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/
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:
02/15/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
2m Associates, Inc.
MARCS-CMS 614195 —
April 12, 2022
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Alpha Bah
Recipient Title
C.E.O. and Owner
2m Associates, Inc.
203 W. 140th St
Apt. 4c
New York
,
NY
10030
United States
Issuing Office:
Division of Northeast Imports
United States
Dear Mr. Alpha Bah:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 614195 issued on 7/20/2021. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Director of Compliance Branch
Division of Northeast Imports
Content current as of:
04/19/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Accurate RX Pharmacy Consulting LLC
MARCS-CMS 604449 —
June 16, 2022
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Jeffrey Lyon
Recipient Title
General Manager
Accurate RX Pharmacy Consulting LLC
Optum Infusion Services
15529 College Blvd
Lenexa
,
KS
66219
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Dear Mr. Lyons:
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_604449) issued on September 2, 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/
Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III
Content current as of:
06/22/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
AcelRx Pharmaceuticals, Inc.
MARCS-CMS 613257 —
March 28, 2022
Product:
Drugs
Recipient:
Recipient Name
Vincent J. Angotti
Recipient Title
Chief Executive Officer
AcelRx Pharmaceuticals, Inc.
25821 Industrial Blvd.
Ste 400
Hayward
,
CA
94545
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Mr. Angotti:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 11, 2021. 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. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP.
Please refer to MA 18 and 23 in addition to the NDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
L. Sheneé Toombs, Pharm.D.
Regulatory Review Officer
Division of Advertising & Promotion Review 1
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.
--------------------------------------------------------------------------------------------
Content current as of:
06/22/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
ACRX Specialty Pharmacy Inc
MARCS-CMS 609518 —
July 13, 2022
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Eghomware J. Igbinovia
Recipient Title
Pharmacist-in-Charge/Owner
ACRX Specialty Pharmacy Inc
3200 Soaring Gulls Dr
STE 101
Las Vegas
,
NV
89129-2198
United States
jerry@acrxpharmacy.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Igbinovia:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [case #: 609518; dated July 24, 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.
If there is any question, please contact LCDR Rumany Penn, compliance officer, at 949-608-4409, or by email at Rumany.Penn@fda.hhs.gov.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
07/15/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Allay Pharmaceuticals, LLC
MARCS-CMS 609023 —
July 18, 2022
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Rosy Sultana
Recipient Title
CEO & President
Allay Pharmaceuticals, LLC
16600 NW 54th Ave
Unit 23
Hialeah
,
FL
33014-6109
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Ms. Sultana:
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 No. 609023) dated January 27, 2021. 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/
Shawn Larson, PhD
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
07/25/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Anna Health, LLC
MARCS-CMS 613294 —
April 04, 2022
Delivery Method:
Electronic  Email
Reference #:
22-HAFE4-WLCOL-07
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Tin Huynh
Recipient Title
Owner
Anna Health, LLC
9724 N Armenia Avenue
Suite 400
Tampa
,
FL
33612-7550
United States
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Mr. Huynh:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 21-HAFE4-WL-03 dated March 16, 2021. 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 East Division IV
Content current as of:
04/08/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Apollo Health And Beauty Care, Inc.
MARCS-CMS 593033 —
July 22, 2022
Reference #:
320-20-15
Product:
Drugs
Recipient:
Recipient Name
Mr. Charles Wachsberg
Recipient Title
Chief Executive Officer
Apollo Health And Beauty Care, Inc.
1 Apollo Place
North York
ON
M3J 0H2
Canada
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Wachsberg:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-15 dated December 23, 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 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/
Michael Klapal
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
07/25/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Ar-Rahman Pharm LLC
MARCS-CMS 614578 —
March 15, 2022
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Sean P. Felder (Abdur-Rahmaan)
Recipient Title
President
Ar-Rahman Pharm LLC
14625 Baltimore Ave
Suite 885
Laurel
,
MD
20707
United States
contact@ar-rahmahpharm.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Felder:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614578, 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:
03/21/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Average Joes Juice LLC
MARCS-CMS 612971 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101481
Product:
Tobacco
Recipient:
Recipient Name
Joseph Fennen
Average Joes Juice LLC
United States
avgjoesjuice@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Joseph Fennen:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated May 4, 2021 and May 10, 2021, in response to our Warning Letter dated January 29, 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.avgjoesjuice.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:
Domains By Proxy, LLC
AVGJOESJUICE.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/07/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Bake’N Joy Foods, Inc.
MARCS-CMS 608975 —
January 14, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Robert M. Ogan
Recipient Title
President and CEO
Bake’N Joy Foods, Inc.
351 Willow Street
North Andover
,
MA
01845
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Ogan:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 608975, issued on October 29, 2020. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
01/18/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Barn Brew LLC dba E-Cig Barn, LLC
MARCS-CMS 612794 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101467
Product:
Tobacco
Recipient:
Recipient Name
Wayne Weigold
Barn Brew LLC dba E-Cig Barn, LLC
United States
admin@ecigbarn.com
lauren@ecigbarn.com
Issuing Office:
Center for Tobacco Products
United States
Dear Wayne Weigold:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated January 19, 2021, January 27, 2021, and February 22, 2021 in response to our Warning Letter dated January 15, 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://ecigbarn.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:
Contact Privacy, Inc.
P62yyjf8u7zd@contactprivacy.email
Google LLC
Registrar-abuse@google.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/07/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Beeyoutiful.com LLC
MARCS-CMS 613682 —
June 07, 2022
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Steven M. Tallent
Beeyoutiful.com LLC
100 Huddleston Street
Centerville
,
TN
37033
United States
steve@beeyoutiful.com
Issuing Office:
Office of Human and Animal Food Operations-East
United States
Dear Mr. Tallent:
The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 613682. Based on our evaluation, it appears 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/
Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
06/10/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
BHP Holdings Inc. dba BioPure Healing Products
MARCS-CMS 597687 —
March 28, 2022
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Brandy D. Floyd
Recipient Title
Chief Executive Officer
BHP Holdings Inc. dba BioPure Healing Products
18538 142nd Avenue NE
Woodinville
,
WA
98072
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Ms. Floyd:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 597687, dated June 17, 2020. 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
Content current as of:
04/01/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Bio-Botanica, Inc./Nature’s Answer, Inc.
MARCS-CMS 613479 —
May 16, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Frank D’Amelio Jr.
Recipient Title
Chief Executive Officer
Bio-Botanica, Inc./Nature’s Answer, Inc.
Nature’s Answer, Inc.
85 Commerce Dr.
Hauppauge
,
NY
11788-3943
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
Dear Mr. D’Amelio Jr.:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 613479, issued on May 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/
Scott Loughan
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
05/23/2022
Regulated Product(s)
Dietary Supplements