tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Abbott
MARCS-CMS 519686 —
April 28, 2020
Recipient:
Recipient Name
Randel Woodgrift
Recipient Title
Senior Vice President
Abbott
15900 Valley View Court
Sylmar
,
CA
91342
United States
mailto:Randel.woodgrift@abbott.com
Issuing Office:
Medical Device & Radiological Health Operations Division 3/West
United States
Dear Mr. Woodgrift:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #519686, April 12, 2017). Based on our evaluation, it appears that your firm has 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/
Jessica Mu, Director of Compliance
Medical Device & Radiological Health Operations
Division 3/West
Content current as of:
05/07/2020
CLOSEOUT LETTER
Aegle Nutrition LLC
MARCS-CMS 546966 —
August 04, 2020
Delivery Method:
VIA UPS and Electronic Mail
Product:
Dietary Supplements
Recipient:
Recipient Name
John Ramsey
Recipient Title
President
Aegle Nutrition LLC
1300 Hutton Drive
Suite 110
Carrollton
,
TX
75006
United States
Issuing Office:
Office of Human and Animal Food-West Div. 3
United States
214-253-5200
Dear Mr. Ramsey:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 546966) on July 6, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Dana M. Lewis
Compliance Officer
Office of Human and Animal Food-West Div. 3
Content current as of:
08/05/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
A.I.G Technologies, Inc.
MARCS-CMS 490872 —
February 18, 2020
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Stephen Dawes
Recipient Title
Technical Director
A.I.G Technologies, Inc.
5001 NW 13th Avenue
Suite B
Deerfield Beach
,
FL
33064
United States
Issuing Office:
Office of Pharmaceutical Quality Operations Division II
United States
Mr. Dawes,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL # 490872 dated December 5, 2017]. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
If you have questions regarding the contents of this letter, you may contact Jamillah Selby via phone at
215-490-8417
or email at
Jamillah.selby@fda.hhs.gov
.
Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
Content current as of:
02/27/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Algunas Inc., dba Woodland Hills Compounding Pharmacy
MARCS-CMS 532739 —
March 25, 2020
Delivery Method:
Via Email
Recipient:
Recipient Name
Dr. Steven A. Levin
Recipient Title
CEO and Owner
Algunas Inc., dba Woodland Hills Compounding Pharmacy
20631 Ventura Blvd.
Suite 305
Woodland Hills
,
CA
91364
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Dr. Levin:
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# 532739) dated July 17, 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/
CDR Steven E Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
03/31/2020
CLOSEOUT LETTER
Alkermes, Inc.
MARCS-CMS 597260 —
September 09, 2020
Recipient:
Recipient Name
Anna Williams
Recipient Title
Associate Director, Regulatory Affairs
Alkermes, Inc.
852 Winter Street
Waltham
,
MA
02451
United States
Issuing Office:
Office of Prescription Drug Promotion
Silver Spring
,
MD
20993
United States
Dear Ms. Williams:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated December 2, 2019. Based on our evaluation, it appears that you have addressed the violation 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 864 in addition to the NDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Nima Ossareh, PharmD, RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
Reference ID: 4668083
--------------------------------------------------------------------------------------------
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/
------------------------------------------------------------
Content current as of:
09/09/2020
CLOSEOUT LETTER
All Access Vapor, LLC
MARCS-CMS 607937 —
August 10, 2020
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001328
Recipient:
Recipient Name
Michael MacArthur, Michael Dade, and Danielle MacArthur
All Access Vapor, LLC
1900 Land O Lakes Blvd.
Suite 107
Lutz
,
FL
33549
United States
info@allaccessvapor.com
mikedade@allaccessvapor.com
mikemac@allaccessvapor.com
Issuing Office:
Division of Promotion, Advertising, and Labeling
United States
Dear Michael MacArthur, Michael Dade, and Danielle MacArthur:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your written response, dated July 3, 2020, in response to our Warning Letter dated May 12, 2020. 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.allaccessvapor.com.
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 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.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
11/05/2020
CLOSEOUT LETTER
Allandale Dairy
MARCS-CMS 582496 —
January 31, 2020
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Scott A. Stangl, Shane Stangl, Craig Stangl
Recipient Title
Co-owner
Allandale Dairy
27231 83rd Street
Pierz
,
MN
56364-7634
United States
Issuing Office:
Office of Human and Animal Food Operations
United States
(612) 334-4100
Dear Messers Stangl:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 582496 dated June 13, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Dianna C. Sonnenburg
Compliance Officer, HAF-W1 CB
Office of Human and Animal Food Operations
Content current as of:
02/05/2020
Regulated Product(s)
Animal & Veterinary
Food & Beverages
CLOSEOUT LETTER
Alternative Laboratories
MARCS-CMS 586947 —
May 21, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WLCOL-10
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Kevin J. Thomas
Recipient Title
CEO
Alternative Laboratories
2231 Linwood Avenue
Naples
,
FL
34112-4737
United States
kevin@alternativelabs.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Thomas:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 19-HAFE4-WL-10 dated September 18, 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/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
05/26/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Annemarie Gianni Skin Care LLC
MARCS-CMS 495979 —
February 12, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Annmarie and Kevin Gianni
Recipient Title
Founders
Annemarie Gianni Skin Care LLC
2251 5th St
Berkeley
,
CA
94710-2216
United States
Issuing Office:
Office of Human and Animal Food Operations East - Division 1
United States
Dear Ms. Gianni and Mr. Gianni:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 495979 dated July 15, 2016. 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/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1
Content current as of:
02/18/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Antonio Mineiro e Andrade
MARCS-CMS 497017 —
May 14, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ildegardo M. Moniz
Recipient Title
Plant Manager
Antonio Mineiro e Andrade
Canada das Vinhas, s/n Rabo de Peixe
Ribeira Grande, Regiao Autonoma dos Acores
9600-095
Portugal
Portugal
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
College Park
,
MD
20740
United States
Dear Mr. Moniz,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 497017, issued on June 28, 2016. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Maria Corpuz
Team Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/21/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Asclemed USA Inc dba Envoachem Pharmeceuticals
MARCS-CMS 575542 —
March 02, 2020
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Robert Nickell
Recipient Title
President/CEO/Owner
Asclemed USA Inc dba Envoachem Pharmeceuticals
379 Van Ness Ave
Suite 1403
Torrance
,
CA
90501
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Mr. Nickell:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 575542, dated June 11, 2019. 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 verify your written commitments.
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 Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
03/04/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Aspen Station/Aspen Pitkin County Airport
MARCS-CMS 535343 —
July 07, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
John Kinney
Recipient Title
Airport Director
Aspen Station/Aspen Pitkin County Airport
0233 E. Airport Road
Suite A
Aspen
,
CO
81611
United States
Issuing Office:
Office of Human and Animal Foods Division IV West
United States
Dear Mr. Kinney:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, reference # HAF4W (DEN)-18-03-WL, issued December 18, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in the referenced 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 Foods
Division IV West
Content current as of:
07/10/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Avicola Santos, Inc.
MARCS-CMS 508164 —
March 03, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
17-SJN-WL-02
Product:
Food & Beverages
Recipient:
Recipient Name
Melvin A. Santos Rodriguez
Recipient Title
Owner
Avicola Santos, Inc.
24 Calle Kennedy
Cidra
,
PR
00739-3405
United States
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Santos Rodriguez:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 17-SJN-WL-02 dated January 17, 2017. 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/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
03/09/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
B & B Pharmaceuticals, Inc.
MARCS-CMS 570613 —
February 06, 2020
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Matthew T. Johnson
Recipient Title
President
B & B Pharmaceuticals, Inc.
8591 Prairie Trail Drive
Suite C-600
Englewood
,
CO
80112
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
19701 Fairchild
Irvine
,
CA
92612-2506
United States
949-608-2900
Dear Mr. Johnson:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 570613, dated June 4, 2019. 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 verify your written commitments.
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 Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
02/10/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
B. Braun Medical Inc.
MARCS-CMS 501232 —
October 22, 2020
Delivery Method:
VIA UPS
Recipient:
Recipient Name
Peter A. Klaes
Recipient Title
Vice President and General Manager, Irvine Operations
B. Braun Medical Inc.
2525 McGaw Avenue
Irvine
,
CA
92614-5841
United States
Issuing Office:
Los Angeles District Office
United States
949-608-2900
Dear Mr. Klaes:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #30-17 dated May 12, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
10/26/2020