tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Magellan Rx Pharmacy, LLC
MARCS-CMS 536134 —
June 06, 2019
Product:
Drugs
Recipient:
Recipient Name
Steffanie M. Mathewson
Recipient Title
Senior Legal Counsel
Magellan Rx Pharmacy, LLC
55 Nod Road
Avon
,
CT
06001
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd
3rd FL
Parsippany
,
NJ
07054
United States
(973) 331-4900
Dear Ms. Mathewson:
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 # 536134) dated September 11, 2017. We acknowledge that your Astoria, New York, facility has closed, effective December 31, 2018, and relinquished its New York State Pharmacy License when the facility closed. 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 assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations, should your facility re-open. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Send your electronic response or request to
orapharm1_responses@fda.hhs.gov
. Please identify your response or related request with FEI #3012729025.
If you have any questions, contact Compliance Officer Juan Jimenez at
juan.jimenez@fda.hhs.gov
or
518-453-2314
X-1014.
/S/
Stephanie Durso
Director Compliance Branch
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Content current as of:
02/03/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Magnus International Group
MARCS-CMS 482353 —
July 09, 2019
Product:
Animal & Veterinary
Recipient:
Recipient Name
Eric E. Lofquist
Recipient Title
President and CEO
Magnus International Group
679 Hardy Road
Painesville
,
OH
44077
United States
Issuing Office:
Center for Veterinary Medicine
6751 Steger Drive
Cincinnati
,
OH
45237
United States
(513) 679-2700
Dear Mr. Lofquist:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 482353 dated February 4, 2016. 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/
Stephen J. Rabe
Compliance Officer
Content current as of:
07/10/2019
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Maine Natural Health, Inc.
MARCS-CMS 525870 —
October 01, 2019
Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Recipient:
Recipient Name
Patricia Leighton
Recipient Title
CEO
Maine Natural Health, Inc.
825 Atlantic Hwy
Warren
,
ME
04864-4617
United States
Issuing Office:
Division of Human and Animal Food Operations East I (HAFE1)
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Ms. Leighton:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 525870, issued on December 19, 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.
Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
10/04/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
MannKind Corporation
MARCS-CMS 578282 —
October 23, 2019
Product:
Drugs
Recipient:
Recipient Name
Susanne Steiner
Recipient Title
Associate Director, Regulatory Affairs
MannKind Corporation
30930 Russell Ranch Road, #300
Westlake Village
,
CA
91362
United States
Issuing Office:
Office of Prescription Drug Promotion
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Ms. Steiner:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter dated October 5, 2018. 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 439 in addition to the NOA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Ankur Kalola, Pharm.D., RAC
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/
ANKUR S KALOLA
10/23/2019 03:34:02 PM
Content current as of:
12/05/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Marukyo Co., Ltd.
MARCS-CMS 571305 —
May 07, 2019
Delivery Method:
Email
Product:
Food & Beverages
Recipient:
Recipient Name
Hiroo Sumi
Recipient Title
President
Marukyo Co., Ltd.
2002-2, Hatagasaki
Yonago
,
Tottori
683-0845
Japan
hinkan@marukyo-seika.co.jp
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Hiroo Sumi:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 571305, issued March 14, 2019. 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/
Mildred P. Benjamin, Branch Chief
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/10/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts
MARCS-CMS 518272 —
March 11, 2019
Delivery Method:
UPS Overnight
Recipient:
Recipient Name
Simeon Georgiou
Recipient Title
Owner
Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts
Maryland Specialty and Compounding Pharmacy
2015 Lord Baltimore Dr.
Baltimore
,
MD
21244
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Georgiou:
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 # 518272) dated April 3, 2017. We acknowledge that your firm no longer produces sterile drug products. 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 assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. 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, please contact Juan Jiménez, Compliance Officer, by telephone at
518-453-2314
X-1014, or by email at
Juan.Jimenez@fda.hhs.gov
.
Sincerely,
/S/
Diana Amador-Toro
Program Division Director
Office of Pharmaceutical Quality Operations – Division I
Cc:   Maryland Specialty and Compounding Pharmacy, LLC
Previously dba Professional Arts Pharmacy
2015 Lord Baltimore Dr.
Baltimore, MD 21244
Content current as of:
03/18/2019
CLOSEOUT LETTER
Maui Preserved, LLC
MARCS-CMS 561637 —
March 22, 2019
Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Anthony M. Labua-Keiser
Maui Preserved, LLC
810 Kokomo Rd
Ste 150
Haiku
,
HI
96708-5081
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
510-337-6700
Dear Mr. Labua-Keiser:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter WL# 561637 dated August 10, 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/
Compliance Branch
Office of Human and Animal Food
Division 5 West
Content current as of:
03/28/2019
CLOSEOUT LETTER
MC Fish Co
MARCS-CMS 552661 —
February 04, 2019
Recipient:
Recipient Name
Michael L. Dye
Recipient Title
Owner
MC Fish Co
MC Fish Co
112 Ferry Street
Milton
,
KY
40045-8244
United States
Issuing Office:
Center for Food Ssafety and Applied Nutrition
United States
Dear Mr. Dye:
The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 552661. 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:
03/04/2019
CLOSEOUT LETTER
Mibo Medical Group
MARCS-CMS 558900 —
November 21, 2019
Delivery Method:
United Parcel Service
Product:
Medical Devices
Recipient:
Recipient Name
Michael Whitehurst
Recipient Title
CEO
Mibo Medical Group
2526 Manana Road
Suite 105
Dallas
,
TX
75220
United States
Issuing Office:
Office of Medical Device & Radiological Health Operations Division 3/West
United States
Dear Mr. Whitehurst:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #558900, November 20, 2018). 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:
12/05/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Michigan Medicine
MARCS-CMS 518396 —
June 13, 2019
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Stanley S. Kent, R.Ph.
Recipient Title
Chief Pharmacy Officer
Michigan Medicine
1500 E. Medical Center Drive
Ann Arbor
,
MI
48109-5008
United States
Issuing Office:
Center for Drug Evaluation and Research
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Kent:
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 #518396, September 28, 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 assure 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
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
06/21/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Millers of Wyckoff, Inc.
MARCS-CMS 484793 —
February 26, 2019
Delivery Method:
UPS Overnight
Recipient:
Recipient Name
David M. Miller, R.Ph
Recipient Title
Owner/President
Millers of Wyckoff, Inc.
Millers of Wyckoff, Inc.
678 Wyckoff Avenue
Wyckoff
,
NJ
07481-1430
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
(973) 331-4900
Dear Mr. Miller:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-NWJ-09, dated June 7, 2016. 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 assure 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/
Stephanie Durso
Director, Compliance Branch
Office of Pharmaceutical Quality Operations
Division I
Content current as of:
03/11/2019
CLOSEOUT LETTER
Molteno Ophthalmic Limited
MARCS-CMS 450427 —
August 02, 2019
Delivery Method:
United States Postal Service
Product:
Medical Devices
Recipient:
Recipient Name
Tess E.S. Molteno
Recipient Title
Managing Director
Molteno Ophthalmic Limited
152 Frederick Street
Dunedin
9016
New Zealand
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mrs. Molteno:
The Food and Drug Administration. (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS 450427, dated February 27, 2015). 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 yours,
/S/
Ronald L. Swann, M.S.
Acting Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health
Content current as of:
08/09/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Morton Drug Company dba Morton LTC
MARCS-CMS 496920 —
June 13, 2019
Delivery Method:
UPS Next Day
Reference #:
MIN 17-01
Product:
Drugs
Recipient:
Recipient Name
Stephen C. Morton
Recipient Title
CEO
Morton Drug Company dba Morton LTC
201 E. Bell Street
Neenah
,
WI
54956-5096
United States
Issuing Office:
Center for Drug Evaluation and Research
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Morton:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to warning letter #MIN 17-01 dated October 26, 2016. Based on our evaluation, it appears that you have adequately addressed the violations contained in the 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 Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
06/18/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
N-Molecular Inc. d.b.a. SOFIE
MARCS-CMS 553833 —
July 02, 2019
Delivery Method:
Certified Mail
Return Receipt Requested
Product:
Drugs
Recipient:
Recipient Name
Patrick W. Phelps
Recipient Title
President and CEO
N-Molecular Inc. d.b.a. SOFIE
SOPHIE Biosciences
6162 Bristol Parkway
Culver City
,
CA
90230
United States
Issuing Office:
Center for Drug Evaluation and Research
10 Waterview Blvd
3rd FL
Parsippany
,
NJ
07054
United States
(973) 331-4900
Dear Mr. Phelps:
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 # 553833) dated September 24, 2018. 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 assure 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/
Stephanie Durso, Compliance Branch Director
Office of Pharmaceutical Quality Operations, Division I
Content current as of:
07/16/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nashoba Brook Bakery, LLC
MARCS-CMS 532236 —
April 03, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
John D. Gates, Stuart J. Witt
Recipient Title
Co-Owner
Nashoba Brook Bakery, LLC
152 Commonwealth Ave.
Concord
,
MA
01742-2990
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Gates and Mr. Witt:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 532236, issued on September 22, 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.
Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Nathan's Soup & Salad Henrietta Inc.
MARCS-CMS 538526 —
February 21, 2019
Recipient:
Recipient Name
Richard M. Torcello
Recipient Title
Owner
Nathan's Soup & Salad Henrietta Inc.
Nathan's Soup & Salad Henrietta Inc.
900 Jefferson Rd. BLDG 3
Rochester
,
NY
14623
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Torcello:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CMS # 538526 dated October 11th, 2017. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
03/08/2019