tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Grams Medical Inc.
MARCS-CMS 482761 —
March 28, 2018
Recipient:
Grams Medical Inc.
United States
Issuing Office:
United States
Office of Medical Device and Radiological Health Operations
Division 3West
19701 Fairchild
Irvine, CA 92612
VIA UNITED PARCEL SERVICE
March 28, 2018
CMS Case ID: 482761
UPS Overnight
Guenter Grams, President and CEO
Grams Medical Inc.
2443 Norse Ave
Costa Mesa, California 92627
Dear Mr. Grams:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 24-16, dated March 17, 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/
Kelly D. Sheppard
Director, Compliance Branch
Content current as of:
05/11/2018
CLOSEOUT LETTER
GS Medical Packaging Inc.
MARCS-CMS 395298 —
October 19, 2018
Recipient:
Recipient Name
John Sherlock
Recipient Title
President
GS Medical Packaging Inc.
82 Akron Road
Unit # 2
Etobicoke
ON
Canada
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993-0002
United States
Dear Mr. Sherlock:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (CMS# 395298) dated June 12, 2013. 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 yours,
/S/
For Ann M. Ferriter
Director
Division of Analysis and Program Operations
Office of Compliance
Center for Devices and Radiological Health
cc:
Alan Schwarts
mdi Consultant, Inc.
55 Northern Blvd ste 200
Great Neck, NY 11021
Content current as of:
10/30/2018
CLOSEOUT LETTER
GumRunner, LLC
March 27, 2018
Recipient:
GumRunner, LLC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
March 27, 2018
Laurence B. Molloy, Co-Owner
Candy Treasure, LLC 66 Welsh Rd.
Lebanon, NJ 08833
Via email:
(b)(6)
@candytreasure.com
Dear Mr. Molloy:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #398518, issued August 22, 2013. 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/
Latasha A. Robinson 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:
04/18/2018
CLOSEOUT LETTER
H. A. R. Maspeth Corp.
MARCS-CMS 434429 —
April 24, 2018
Recipient:
H. A. R. Maspeth Corp.
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
April 24, 2018
Ms. Elizabeth Kwon, President/Owner
H.A.R. Maspeth Corp.
44-28 55th Avenue
Maspeth, NY 11378-1042
Dear Ms. Kwon:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2014-48, issued on July 22, 2014. 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:
04/25/2018
CLOSEOUT LETTER
Hacienda Morales dba Granja Avicola Morales
June 07, 2018
Recipient:
Hacienda Morales dba Granja Avicola Morales
United States
Issuing Office:
United States
Office of Regulatory Affairs
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500
June 07, 2018
18-HAFE4-WLCOL-06 / CMS No. 397823
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Mr. Samuel Morales Arce, Owner
Hacienda Morales dba Granja Avicola Morales
Road 404, Km. 8.6
Moca, Puerto Rico 00676
Re: Warning Letter, 13-SJN-WL-06 dated 09/23/2013
Dear Mr. Morales:
During a follow-up visit to your facility during 07/31/2017 - 08/01/2017 by a Food and Drug Administration investigator, it was determined that your firm is out-of-business. It appears that the violations contained in the Warning Letter, 13-SJN-WL-06, dated 09/23/2013, will not require additional FDA inspection activities. However, should you decide to resume business operations that fall under the registration requirements in Sec. 415 of the Federal Food, Drug and Cosmetics Act (the Act), [21 USC § 350d] and its implementing regulation 21 CFR Part 1, Subpart H, you must register the facility with FDA.
Registration may be accomplished on-line at
http://www.access.fda.gov
. We strongly encourage the use of electronic registration, because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of the facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA Food Facility Registration form, Form FDA 3537 (enclosed). Additionally, this form may be obtained by calling the FDA Industry Systems Help Desk at 1 (800) 216-7331 or (301) 575-0156 or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5100 Paint Branch Parkway
College Park, MD 20993
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.
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. This letter will not preclude any future regulatory action should violations be observed during subsequent inspections or through other means.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO East Division IV
Content current as of:
06/11/2018
CLOSEOUT LETTER
Hahn's Old Fashioned Cake Company, Inc.
February 28, 2018
Recipient:
Hahn's Old Fashioned Cake Company, Inc.
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUEST
February 28, 2018
Mrs. Regina Hahn, President and Co-Owner
Hahn’s Old Fashioned Cake Company, Inc.
75 Allen Boulevard
Farmingdale, NY 11735
Dear Mrs. Hahn:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2014-28, issued on April 17, 2014. 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:
02/28/2018
CLOSEOUT LETTER
Healing Noni Co., LLC
MARCS-CMS 492662 —
March 02, 2018
Recipient:
Healing Noni Co., LLC
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway, Alameda, CA 94502
Telephone:
510-337-6700
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
March 2, 2018
Michael D. Harvey, Owner
Healing Noni Co. L.L.C.
13-1399 Kamaili Rd.
Pahoa, HI 96778
P.O. Box 5884
Hilo, HI 96720
RE: WL #492662 Close-Out Letter
Dear Mr. Harvey:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [WL#492662 issued August 26, 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/
Darla Bracy, District Director
Office of Human and Animal Food
Division 5 West
Content current as of:
03/26/2018
CLOSEOUT LETTER
Health Innovations Pharmacy, Inc
MARCS-CMS 489187 —
April 21, 2018
Recipient:
Health Innovations Pharmacy, Inc
United States
Issuing Office:
United States
Office of Pharmaceutical Quality Operations, Division 2
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
April 21, 2018
Mr. Timothy H. Clark, Owner
Health Innovations Pharmacy, Inc.
295 Pinehurst Avenue
Southern Pines, North Carolina 28387
Mr. Clark:
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 #16-ATL-16] issued on July 8, 2016. 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 you have additional questions, please contact me at
(214) 253-5288
or
john.diehl@fda.hhs.gov
.
Sincerely,
/S/
LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division 2
Content current as of:
07/31/2018
CLOSEOUT LETTER
Healthy Healing dba Crystal Star
MARCS-CMS 543429 —
September 11, 2018
Recipient:
Recipient Name
Dr. Linda Page
Healthy Healing dba Crystal Star
9821 Valley View Rd
Eden Prairie
,
MN
55344-3527
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Dr. Page:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 543429, issued January 11, 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/
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:
09/24/2020
CLOSEOUT LETTER
HLS Aqua Products
MARCS-CMS 486525 —
October 05, 2018
Recipient:
Recipient Name
Hem P. Villaluna
HLS Aqua Products
HLS Aqua Products
Hiccor Compound
Araneta Street
Bacolod City
Philippines
Issuing Office:
Public Health Service
College Park
,
MD
20740
United States
Dear Mr. Villaluna:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #486525, issued February 5, 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/
Brandon Bridgman
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/09/2018
CLOSEOUT LETTER
Homeocare Laboratories, Inc.
MARCS-CMS 521717 —
June 25, 2018
Recipient:
Homeocare Laboratories, Inc.
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone:
(973) 331-4900
FAX:
(973) 331-4969
CERTIFIED MAIL
RETURN RECIPT REQUESTED
June 25, 2018
Edith Scheiner, President
HomeoCare Labs Inc.
7 Odell Plaza, Suite 142-146
Yonkers, NY 10701
Dear Ms. Scheiner:
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 # 521717) dated September 7, 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/
Yvette Johnson, Compliance Officer
Office of Pharmaceutical Quality Operations, Division I
Philadelphia District Office
Content current as of:
06/26/2018
CLOSEOUT LETTER
Horizon Pharmaceuticals, Inc.
MARCS-CMS 485363 —
February 19, 2018
Delivery Method:
UPS NEXT DAY DELIVERY
Signature Required
Product:
Drugs
Recipient:
Recipient Name
Ehab Ibrahim
Recipient Title
CEO
Horizon Pharmaceuticals, Inc.
7880 Central Industrial Drive
Riviera Beach
,
FL
33404
United States
Issuing Office:
Center for Drug Evauation and Research
4040 North Central Expressway
Suite 300
Dallas
,
TX
75205
United States
Dear Mr. Ibrahim:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-17-06 dated December 23, 2016. Based on our evaluation during the August 05, 2017 inspection of your firm, 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/
LCDR John W. Diehl, M.S.
Compliance Branch Director
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
08/28/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hospira Inc
MARCS-CMS 506761 —
June 27, 2018
Recipient:
Hospira Inc
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI 48207
Telephone:
(313) 393-8100
Fax:
(313) 393-8139
June 27, 2018
UPS NEXT DAY
SIGNATURE REQUIRED
Mr. Ian C. Reed
Chairman and CEO
Pfizer Inc.
235 East 42nd St.
New York, NY 10017
Dear Mr. Reed:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from October 16-27, 2017.
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case 506761). Any continued concerns regarding your Warning Letter response will be addressed in additional correspondence. Based on our current 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/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations Division III
cc:
Mr. Jonathan J. Rushford
Vice President Operations/Site Head
1776 Centennial Dr.
McPherson, KS 67460
Content current as of:
07/25/2018
CLOSEOUT LETTER
Hsien-Pin Frozen Foods Co., Ltd.
February 02, 2018
Recipient:
Hsien-Pin Frozen Foods Co., Ltd.
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
February 2, 2018
Mr. Wen-Pin Liu
President
Hsien-Pin Frozen Foods Co. Ltd.
21 Zyquiang Rd.
Su-Ao Township
Ylan, 270, Taiwan
Dear Mr. Wen-Pin Liu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 486186, issued January 14, 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 G. Corpuz, Team Leader
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/07/2018