tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Natural Sea Product Co., Ltd.
MARCS-CMS 562272 —
July 21, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Paramesawa Sornsong
Recipient Title
Managing Director/Owner
Natural Sea Product Co., Ltd.
29/6, Moo 3
Tambol Bangyapak
Muang
,
Samut Sakhon
74000
Thailand
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Paramesawa Sornsong:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 562272, issued September 4, 2018. 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, Supervisor
Food Adulteration Assessment Branch
Division of Enforcement
Center for Food Safety and Applied Nutrition
Content current as of:
07/23/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Nature's Vision, Inc
MARCS-CMS 510903 —
February 14, 2019
Recipient:
Recipient Name
Kim D. Burco
Recipient Title
Owner
Nature's Vision, Inc
7320 Garden Lane
Portage
,
MI
49002
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
(312) 353-5863
Dear Ms. Burco,
The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 2017-DET-05, dated May 1, 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/
Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Division East 6
Content current as of:
03/08/2019
RESPONSE LETTER
Niche Pharmaceuticals, Inc
July 08, 2019
Company:
Niche Pharmaceuticals, Inc
580 Commerce St.
Ste. 100
Southlake
,
TX
76092-9156
United States
817-421 -2777
Recipient:
Dana Lewis
Compliance Officer
United States
Dear Ms. Lewis,
This letter is a follow-up to our discussion regarding the Warning Letter received by Niche Pharmaceuticals, Inc. on July 19, 2018. Case 553911. Pursuant to the Agency's request Niche Pharmaceuticals, Inc. has reformulated its product Mag-Tab SR to remove yellow dye #10 from the formulation. The caplet now contains "
(b)(4)
white" which is approved for dietary supplements as a colorant. As allowed by the CFSAN, all existing yellow caplets were sold by about April 1, 2019. All current inventory and sales are now yellow dye free and are white coated caplets.
Further to the Warning Letter, we edited our website shortly after receiving the letter to remove the few items cited as drug claims in the Metabolic section as well as a few testimonials.
As such we are requesting the FDA to update their action with a follow-up letter stating that Niche Pharmaceuticals, Inc. is "in compliance" with the stated Warning Letter demands.
Sincerely,
/S/
Stephen F. Brandon Sr. - CEO
Niche Pharmaceuticals, Inc.
Content current as of:
08/15/2019
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Niche Pharmaceuticals, Inc
MARCS-CMS 553911 —
August 13, 2019
Delivery Method:
UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Stephen F. Brandon, Sr.
Recipient Title
Owner & CEO
Niche Pharmaceuticals, Inc
580 Commerce Street
Ste. 100
Southlake
,
TX
76092-9156
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
4040 North Central Expressway
Suite 300
Dallas
,
TX
75204-3138
United States
Dear Mr. Brandon:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 553911) on June 19, 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:
08/15/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Nutraloid Labs Inc
MARCS-CMS 481382 —
October 01, 2019
Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Recipient:
Recipient Name
Bartholomew Panessa
Recipient Title
Owner
Nutraloid Labs Inc
120 Woods Rd
Building #2
Kingston
,
NY
12401
United States
Issuing Office:
Division of Human and Animal Food Operations East I (HAFE1)
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Panessa:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2016-19, issued on January 8, 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 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
Nutrition Coalition Inc
MARCS-CMS 566090 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Kolleen Sunde
Nutrition Coalition Inc
2420 20th Ave S
Moorhead
,
MN
56560
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Sunde:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 566090, issued February 5, 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/06/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Option Care Enterprises, Inc. dba Option Care
MARCS-CMS 527394 —
December 20, 2019
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Kimberly I. Young
Recipient Title
Director of Operations
Option Care Enterprises, Inc. dba Option Care
9601 Baptist Health Drive
Suite 330
Little Rock
,
AR
72205-6323
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II (PHRM2)
United States
Ms. Young:
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 #527394 dated September 12, 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.
If you have questions regarding the contents of this letter, you may contact Rebecca A. Asente, Compliance Officer, via
(504) 846-8104
or
Rebecca.asente@fda.hhs.gov
.
Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
12/30/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Orangeburg Pecan Company Inc
MARCS-CMS 544396 —
December 20, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Frederick J.D. Felder
Recipient Title
President
Orangeburg Pecan Company Inc
761 Russell St.
Orangeburg
,
SC
29115-5819
United States
Issuing Office:
Office of Human and Animal Foods- Division 3 East
United States
Dear Mr. Felder,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning letter dated May 17, 2018. Based on our evaluation during the recent November 18-19, 2019 visit to your facility located at 11251 NC Highway 903, Halifax, NC 27839-9073, it appears that you have addressed the violation(s) 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.
If you have any questions regarding this letter, you may contact Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. You may also contact Ms. King at
(843) 746-2990
x16 or via email at
janice.king@fda.hhs.gov
.
Sincerely,
/S/
Janice L. King
Compliance Officer
U.S. Food & Drug Adminisration
Office of Human and Animal Foods-Division 3 East
(Georgia- North Carolina-South Carolina)
Cc: Atlanta File- [Orangeburg Pecan-FEI: 1011345]
Content current as of:
01/06/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Orchid Orthopedic Solutions, LLC
MARCS-CMS 580112 —
May 13, 2019
Delivery Method:
Via Email
Product:
Medical Devices
Recipient:
Recipient Name
Nathan A. Folkert
Recipient Title
Chief Executive Officer
Orchid Orthopedic Solutions, LLC
CEP Bio-Coat, LLC
1489 Cedar Street
Holt
,
MI
48842
United States
Nate.Folkert@orchid-ortho.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Folkert:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 580112) issued on May 13, 2019, at CEP Bio-Coat/Orchid Orthopedic Solutions, LLC, located at 23149 Commerce Drive, Farmington Hills, MI,, FEI 3011277306. 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 yours,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
01/24/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Orthosoft, Inc. dba Zimmer CAS
MARCS-CMS 496307 —
August 02, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Louis-Philippe Amiot
Recipient Title
Vice President and General Manager
Orthosoft, Inc. dba Zimmer CAS
3300-75 Queen Street
Montreal
H3C 2N6
Canada
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Louis-Philippe Amiot:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 496307, dated May 27, 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
08/06/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Park Infusioncare LP dba Preferred Homecare
MARCS-CMS 547494 —
June 12, 2019
Product:
Drugs
Recipient:
Recipient Name
Mr. Robert Fahlman
Park Infusioncare LP dba Preferred Homecare
4601 East Hilton Ave., Suite 100
Phoenix
,
AZ
85034
United States
Issuing Office:
Dallas District Office
United States
June 12, 2019
Case #547494
VIA UPS EXPRESS
Robert Fahlman, Chief Executive Officer
Preferred Homecare (Corporate Office)
4601 East Hilton Ave., Suite 100
Phoenix, Arizona 85034-6406
Mr. Fahlman:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (Case #547494), dated March 1, 2018. We acknowledge that your firm, located at 13621 Inwood Road, Suite 420, Dallas, Texas 75244-4654, was sold to Coram CVS Specialty Infusion Services and closed for business on March 9, 2018.
If you decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to beginning drug production. 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.
If you have any questions regarding this letter, please contact me at (214) 253-5288 or via e-mail at John.Diehl@fda.hhs.gov.
Sincerely,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division 2
Content current as of:
06/12/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy
MARCS-CMS 524550 —
April 22, 2019
Product:
Drugs
Recipient:
Recipient Name
Christopher M. Schulte
Recipient Title
Owner
Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy
6506 N. Davis Highway
Pensacola
,
FL
32504-6957
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Mr. Schulte:
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 Case #524550; June 28, 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. 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 about this information, please contact Jose R. Lopez, Compliance Officer, at
(787) 729-8603
, or by email at
JoseR.Lopez@fda.hhs.gov
.
Sincerely,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
04/24/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
PharmScript, LLC
MARCS-CMS 535618 —
July 29, 2019
Reference #:
#17-NWJ-11
Product:
Drugs
Recipient:
Recipient Name
Michael Segal
Recipient Title
CEO
PharmScript, LLC
150 Pierce Street
Somerset
,
NJ
08873
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. Segal:
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 #17-NWJ-11; dated August 23, 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/
Diana Amador-Toro
Program Division Director/District Director
OPQO Division I
New Jersey District Office
Content current as of:
08/07/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Pine Creek General Store
MARCS-CMS 542508 —
May 02, 2019
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Reuben M. Yoder, Edna M. Yoder
Recipient Title
Owners
Pine Creek General Store
Ozark Country Herbs
2866 Highway 395 North
Salem
,
AR
72576
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. and Mrs. Yoder
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: CMS # 542508), dated March 30, 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. If you choose to reestablish or sale your operations, the Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Jessica Hensley
Director of Compliance
Office of Human and Animal Food W-3
Content current as of:
05/08/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Pine Pharmacy and Home Care Products Center, Inc.
MARCS-CMS 435704 —
April 25, 2019
Delivery Method:
UPS Next Day Air
Reference #:
NYK-2015-24
Product:
Drugs
Recipient:
Recipient Name
Alfonse Muto, Sr.
Recipient Title
Owner
Pine Pharmacy and Home Care Products Center, Inc.
5110 Main Street
Williamsville
,
NY
14221
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
(973) 331-4900
Dear Mr. Muto:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of (your/your firm’s) corrective actions in response to our warning letter (ref: NYK-2015-24), dated February 13, 2015. 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/
Diana Amador-Toro
Program Division Director/District Director
Office of Pharmaceutical Quality Operations - Division I
New Jersey District Office
Content current as of:
06/03/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Positive Power Nutrition
MARCS-CMS 496026 —
April 24, 2019
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Burt D. Goulding Jr.
Recipient Title
President
Positive Power Nutrition
26346 Madison Ave
Murrieta
,
CA
92562
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Burt D. Goulding Jr.:
The Food and Drug Administration has completed an evaluation of Positive Power Nutrition corrective actions in response to our Warning Letter 496026 dated September 15, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
05/07/2019
Regulated Product(s)
Food & Beverages